Source NCIt Subset Code FDA Subset Name NCIt Concept Code FDA Source PT FDA Source Synonyms(s) FDA Source Definition NCIT Definition FDA C106039 FDA CDRH GUDID Terminology C45329 Active Exerting influence or producing an effect. FDA C106039 FDA CDRH GUDID Terminology C118639 Active (Implanted) An appliance or mechanism that continues to be implanted. FDA C106039 FDA CDRH GUDID Terminology C160949 AIDC UDI A method of encoding a UDI (and possibly other information) on a low cost and portable device that can be detected by a computer system. FDA C106039 FDA CDRH GUDID Terminology C67505 Angle The inclination of one line to another or the plane of one object to another. The inclination of one line to another or the plane of one object to another. FDA C106039 FDA CDRH GUDID Terminology C25244 Area The extent of a 2-dimensional surface enclosed within a boundary. The extent of a 2-dimensional surface enclosed within a boundary. FDA C106039 FDA CDRH GUDID Terminology C150200 Atherectomy Device Tip Length The length of the tip of the atherectomy device, if present. The length of the tip of the atherectomy device, if present. FDA C106039 FDA CDRH GUDID Terminology C150163 Balloon Catheter Tip Length The length of the distal end of the catheter to the distal end of the balloon. The length of the distal end of the catheter to the distal end of the balloon. FDA C106039 FDA CDRH GUDID Terminology C150145 Balloon Diameter Nominal Diameter The nominal diameter of the balloon per manufacturer specification. The nominal diameter of the balloon per manufacturer specification. FDA C106039 FDA CDRH GUDID Terminology C150146 Balloon Length Nominal Diameter The nominal length of the balloon per manufacturer specification. The nominal length of the balloon per manufacturer specification. FDA C106039 FDA CDRH GUDID Terminology C43361 Barcode A machine-readable representation of information in a visual format on a surface. FDA C106039 FDA CDRH GUDID Terminology C71778 Biologics License Application A category specifying that a product is marketed under a Biologic License Application.|Stability data submitted to a biologics license application. A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs. FDA C106039 FDA CDRH GUDID Terminology C160947 Card A card which contains data for automatic processing of an item. FDA C106039 FDA CDRH GUDID Terminology C99286 Catalog Number The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. The identifier assigned to a product, usually in the list of products published by a reseller or manufacturer. FDA C106039 FDA CDRH GUDID Terminology C150184 Catheter Length The length of the catheter. The length of the catheter. FDA C106039 FDA CDRH GUDID Terminology C150186 Catheter Working Length Effective Length|Working Length The length of the catheter that can be inserted into the body or the working/functional measurement from the beginning to the end of delivery system. The length of the catheter that can be inserted into the body or the working/functional measurement from the beginning to the end of delivery system. FDA C106039 FDA CDRH GUDID Terminology C101691 Chlorine Dioxide A sterilization process that uses chlorine dioxide gas at ambient temperatures and low concentrations to kill microorganisms. A sterilization process that uses chlorine dioxide at ambient temperatures to kill microorganisms. This process can be used in large spaces. FDA C106039 FDA CDRH GUDID Terminology C64265 Circumference The length of the closed curve of a circle; the size of something as given by the distance around it. FDA C106039 FDA CDRH GUDID Terminology C54696 Combination Product A product comprised of two or more regulated components, i.e., drug and device, biologic and device, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; or two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; or a drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect. FDA C106039 FDA CDRH GUDID Terminology C150229 Crossing Profile Catheter Gauge|Catheter Size The maximum diameter of the entire device entering the patient. ASTM F2081 definition: A linear measure of the maximum breadth of the stent/delivery system over the distal most region of the delivery system. A linear measure of the maximum breadth of the stent/delivery system over the distal most region of the delivery system. FDA C106039 FDA CDRH GUDID Terminology C101708 Customer Contact A public-facing customer contact for the Labeler company responsible to support the reported device. Customer contact information for a device labeler. FDA C106039 FDA CDRH GUDID Terminology C150233 Cutter Diameter The diameter of the cutter component for atherectomy devices that is used to cut the plaque/thrombus. The diameter of the cutter component for atherectomy devices that is used to cut the plaque/thrombus. FDA C106039 FDA CDRH GUDID Terminology C150230 Cutter Length The length of the cutter component for atherectomy devices that are used to cut plaque/thrombus. The length of the cutter component for atherectomy devices that are used to cut plaque/thrombus. FDA C106039 FDA CDRH GUDID Terminology C121843 De Novo Classification Request A premarket submission made to the FDA for classification of a device for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. A premarket submission made to the FDA for classification of a device for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. FDA C106039 FDA CDRH GUDID Terminology C25333 Depth The extent downward or inward; the perpendicular measurement from the surface downward to determine deepness. FDA C106039 FDA CDRH GUDID Terminology C160939 Device Implantable Status The status of the implantable device. FDA C106039 FDA CDRH GUDID Terminology C101676 Device is Packaged as Sterile The medical device is free from viable microorganisms. See ISO/TS 11139. A device is packaged as being free of any living organisms. FDA C106039 FDA CDRH GUDID Terminology C53602 Device Labeled for Single Use A device that is intended for one use, or on a single patient during a single procedure (Title 21 Chapter 9 Federal Food, Drug and Cosmetic Act). FDA C106039 FDA CDRH GUDID Terminology C106041 Device Size Text Additional undefined device size not represented in the GUDID clinically relevant size list. Information about the size of the device that is not represented elsewhere. FDA C106039 FDA CDRH GUDID Terminology C160943 Device Status The current status of the device. FDA C106039 FDA CDRH GUDID Terminology C101678 DM DI Number An identifier that is marked directly on the medical device and is different than the Primary DI; only applicable to devices subject to Direct Marking requirements under 21 CFR 801.50. An identifier that is marked directly on a device. FDA C106039 FDA CDRH GUDID Terminology C113843 Donation Identification Number Production Identifier The number assigned to a device containing human cellular or tissue components (HCT/P) which relates the HCT/P product to the donor and all records pertaining to the HCT/P product. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. A number assigned to a device that contains human cells or tissue. The number can be found on the device label or packaging. FDA C106039 FDA CDRH GUDID Terminology C101712 Dry Heat Sterilization A sterilization process that uses high temperature and dry air to kill microorganisms. A sterilization process that uses high temperature and dry air to kill microorganisms on the surface of objects. This process is restricted to objects that can withstand high temperatures. FDA C106039 FDA CDRH GUDID Terminology C101713 Ethylene Oxide A sterilization process that uses ethylene oxide (EtO) gas to kill microorganisms. A sterilization process that uses ethylene oxide gas to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C80438 Exempt Device A medical device that is exempt from FDA premarket notification requirements. FDA C106039 FDA CDRH GUDID Terminology C101679 Exempt from Direct Marking (DM) The device meets the requirements stipulated under 21 CFR, but is exempt from Direct Marketing. An indication that a device is exempt from direct marking requirements. FDA C106039 FDA CDRH GUDID Terminology C101670 Expiration Date Production Identifier The date by which the label of a device states the device must or should be used. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. The production identifier is the expiration date. FDA C106039 FDA CDRH GUDID Terminology C101677 FDA Listing Number Number assigned by FDA during Registration and Listing to all devices in commercial distribution, regardless of pre-market authorization requirements, per 21 CFR 807.28(f). See 21 CFR 807 for all Registration and Listing requirements. A number assigned by the FDA to a device during Registration and Listing. FDA C106039 FDA CDRH GUDID Terminology C48161 Force The influence that produces a change in a physical quantity; physical energy or intensity. FDA C106039 FDA CDRH GUDID Terminology C101680 French Catheter Gauge A number representing the outer diameter of a catheter where each integer represents 1/3 of a millimeter. A number representing the outer diameter of a catheter where each integer represents 1/3 of a millimeter. FDA C106039 FDA CDRH GUDID Terminology C101716 Global Unique Device Identification Database Submission GUDID The submission of a DI Record through SPL XML Message as a type of SPL Document. The submission of a global unique device identification record. FDA C106039 FDA CDRH GUDID Terminology C150185 Guidewire Compatibility Inner Lumen Dimension|Maximum Guidewire Size The size of the guidewires that will fit through the inner lumen of the device. The size of the guidewires that will fit through the inner lumen of the device. FDA C106039 FDA CDRH GUDID Terminology C150372 Guidewire Diameter The diameter of the guidewire. The diameter of the guidewire. FDA C106039 FDA CDRH GUDID Terminology C150371 Guidewire Length The length of the guidewire. The length of the guidewire. FDA C106039 FDA CDRH GUDID Terminology C101681 Handling Environment Atmospheric Pressure Handling requirements that are indicated for the device; atmospheric pressure under which the product should be operated, e.g., 1000 - 1100 hPa. The recommended atmospheric pressure for handling or operating a device. FDA C106039 FDA CDRH GUDID Terminology C101682 Handling Environment Humidity Handling requirements that are indicated for the device; relative humidity in volume percent under which the product should be operated, e.g., 0 - 20 %. The recommended humidity level for handling or operating a device. FDA C106039 FDA CDRH GUDID Terminology C101683 Handling Environment Temperature Handling requirements that are indicated for the device; environmental temperature range under which the device may be operated. The recommended temperature of the environment when handling or operating a device. FDA C106039 FDA CDRH GUDID Terminology C25347 Height The vertical measurement or distance from the base to the top of an object; the vertical dimension of extension. FDA C106039 FDA CDRH GUDID Terminology C101693 High Intensity Light or Pulse Light A sterilization process that uses intense and short duration pulses of wavelengths of light from the ultraviolet to the near infrared regions to kill microorganisms. A sterilization process that involves the pulsing of a high-power xenon lamp. This process kills microorganisms through the high ultraviolet content of the light and the brief heating effects. FDA C106039 FDA CDRH GUDID Terminology C107419 High Level Disinfectant A germicide that inactivates all microbial pathogens, except small numbers of bacterial endospores. A sterilization method that uses a disinfectant for a period of time to kill all microorganisms except small numbers of bacterial spores. FDA C106039 FDA CDRH GUDID Terminology C101674 Human Cell, Tissue, or Cellular or Tissue-based Product HCT/P Human cell, tissue, or cellular or tissue-based product (HCT/P) contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. A product that contains human cells or tissue. FDA C106039 FDA CDRH GUDID Terminology C80440 Humanitarian Device Exemption Stability data submitted for an HDE application. A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA. FDA C106039 FDA CDRH GUDID Terminology C101689 Hydrogen Peroxide A sterilization process that uses radicals that form from hydrogen peroxide to kill microorganisms. A sterilization process that uses hydrogen peroxide to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C154407 Inactive Not progressing or moving. FDA C106039 FDA CDRH GUDID Terminology C114146 Inactive (Removed) A finding referring to a medical device that has been removed from the body, usually during a surgical procedure. FDA C106039 FDA CDRH GUDID Terminology C128461 Inches of Mercury A measurement of the pressure exerted by a column of mercury of 1 inch in height at the standard acceleration of gravity. This measurement is used for barometric pressure in aviation, refrigeration, and weather reports. The conversion to metric units is dependent upon the temperature of the mercury. A measurement of the pressure exerted by a column of mercury of 1 inch in height at the standard acceleration of gravity. This measurement is used for barometric pressure in aviation, refrigeration, and weather reports. The conversion to metric units is dependent upon the temperature of the mercury. FDA C106039 FDA CDRH GUDID Terminology C150226 Inner Diameter The measurement of the diameter of the inner catheter tubing which goes over the guidewire. The measurement of the diameter of the inner catheter tubing which goes over the guidewire. FDA C106039 FDA CDRH GUDID Terminology C101685 Inner/Lumen Diameter The length of a straight line passing through the center of the inner open space or cavity of a circular or spheroid object (such as a tubular organ) that connects two points on the circumference. The length of a straight line passing through the center of the inner open space of a circular or spheroid object that connects two points on the circumference. FDA C106039 FDA CDRH GUDID Terminology C150144 Introducer Sheath Compatibility Introducer Size|Sheath Compatibility|Sheath Size The size of the device that would fit through an introducer sheath. The size of the device that would fit through an introducer sheath. FDA C106039 FDA CDRH GUDID Terminology C50021 Kit A collection of objects or devices collected together for a particular function or purpose. FDA C106039 FDA CDRH GUDID Terminology C101673 Labeled as Containing Natural Rubber Latex The device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. The device must be labeled with one of the following statements: (1) Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions, (2) This Product Contains Dry Natural Rubber, (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions or (4) The Packaging of This Product Contains Dry Natural Rubber. The device label indicates natural rubber latex as a component. FDA C106039 FDA CDRH GUDID Terminology C101684 Labeler Any person who causes a label to be applied to a device with the intent that the device will be introduced into interstate commerce without any intended subsequent replacement or modification of the label; and any person who causes the label of a device to be modified with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler. Per 21 CFR 801.3. An individual that labels a device. FDA C106039 FDA CDRH GUDID Terminology C113844 Labeling does not contain MRI Safety Information Information on the safety of using a device in a magnetic resonance (MR) environment has not been provided in the labeling by the labeler. This information is not required by FDA regulation or the UDI Rule. Information on the safety of using a device in a magnetic resonance (MR) environment has not been provided in the labeling by the labeler. FDA C106039 FDA CDRH GUDID Terminology C160938 Latex Safety FDA C106039 FDA CDRH GUDID Terminology C25334 Length The linear extent in space from one end of something to the other end, or the extent of something from beginning to end. FDA C106039 FDA CDRH GUDID Terminology C107418 Liquid Chemical Sterilant A sterilization process that uses liquid chemical as its sterilant to kill microorganisms. A sterilization process to kill microorganisms using a liquid sterilant. FDA C106039 FDA CDRH GUDID Terminology C101672 Lot or Batch Number Production Identifier The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. The production identifier is the lot or batch number. FDA C106039 FDA CDRH GUDID Terminology C122711 Malfunctioning A medical device that is functioning incorrectly. FDA C106039 FDA CDRH GUDID Terminology C63513 Manual Of or related to the hands; reference to a task or activity being done by hand (as opposed as being performed with the assistance of automation or other supportive means). FDA C106039 FDA CDRH GUDID Terminology C101669 Manufacturing Date Production Identifier The date on which a device was manufactured. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. The production identifier is the date of manufacture. FDA C106039 FDA CDRH GUDID Terminology C150197 Maximum Stent Diameter Maximum diameter to which a stent can be distended. Maximum diameter to which a stent can be distended. FDA C106039 FDA CDRH GUDID Terminology C101694 Microwave Radiation A sterilization process that uses nonionizing radiation at frequencies between 300MHz and 300GHz in the microwave region to kill microorganisms. A sterilization process that uses microwave radiation to kill microorganisms. This process is restricted to materials that contain water and is typically used for food. FDA C106039 FDA CDRH GUDID Terminology C49670 Millimeter of Mercury A non-SI unit of pressure equal to 133,332 Pa or 1.316E10-3 standard pressure. Use of this unit is generally deprecated by ISO or IUPAC. A non-SI unit of pressure equal to 133,332 Pa or 1.316E10-3 standard atmosphere. Use of this unit is generally deprecated by ISO and IUPAC. FDA C106039 FDA CDRH GUDID Terminology C99285 Model Number The identifier assigned to a particular design of a device. FDA C106039 FDA CDRH GUDID Terminology C101714 Moist Heat or Steam Sterilization A sterilization process that uses moist air at high temperatures to kill microorganisms. A sterilization process that uses high temperature and moist air to kill microorganisms. The moist air is typically applied at increased atmospheric pressure and the process is restricted to objects that can withstand high temperature and pressure. FDA C106039 FDA CDRH GUDID Terminology C106046 MR Conditional A device with demonstrated safety in the MR environment within defined conditions. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and the radiofrequency fields. Additional conditions, including specific configurations of the item, may be required. See ASTM F2503. Reprinted, with permission, from F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. A device with demonstrated safety in the MR environment within defined conditions. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and the radiofrequency fields. Additional conditions, including specific configurations of the item, may be required. See ASTM F2503. FDA C106039 FDA CDRH GUDID Terminology C106045 MR Safe The device poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic. See ASTM F2503. Reprinted, with permission, from F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. The device poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic. See ASTM F2503. FDA C106039 FDA CDRH GUDID Terminology C106047 MR Unsafe The device which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. See ASTM F2503. Reprinted, with permission, from F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. The device which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. See ASTM F2503 FDA C106039 FDA CDRH GUDID Terminology C106044 MRI Safety Labeling Information This data element identifies what, if any, information on MRI Safety is presented by the labeler in the device labeling. Safety information about the MRI device that is included on the device label. FDA C106039 FDA CDRH GUDID Terminology C106043 Natural Rubber Latex Any material made from or containing natural latex in its native liquid or colloidal state. Natural latex is an extract of the rubber tree (H. brasiliensis) and contains the allergens responsible for latex hyper-sensitivity reactions. Products that may contain NRL are medical gloves and condoms. See 21 CFR 801.437 for full regulatory definition. The natural extract of tropical rubber plants. FDA C106039 FDA CDRH GUDID Terminology C101687 Needle Gauge A number representing the outer diameter of a hypodermic needle. A number representing the outer diameter of a hypodermic needle. FDA C106039 FDA CDRH GUDID Terminology C72899 New Drug Application A type of application which a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested.|Stability data submitted to a new human drug application. A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND). FDA C106039 FDA CDRH GUDID Terminology C107416 Nitrogen Dioxide A sterilization process that uses nitrogen dioxide radicals that are formed from dinitrogen tetroxide dimers to kill microorganisms. A sterilization process that uses nitrogen dioxide to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C150147 Nominal (Inflation) Pressure Balloon pressure at balloon nominal diameter condition. Balloon pressure at balloon nominal diameter condition. FDA C106039 FDA CDRH GUDID Terminology C150189 Nominal Stent Diameter Stent Diameter Deployed stent diameter, as marked on packaging. Deployed stent diameter, as marked on packaging. FDA C106039 FDA CDRH GUDID Terminology C150190 Nominal Stent Length Stent Length Deployed stent length, as marked on the packaging. Deployed stent length, as marked on the packaging. FDA C106039 FDA CDRH GUDID Terminology C106038 Not Made with Natural Rubber Latex Natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Not all medical products that are NOT made with natural rubber latex will be marked. The composition of the materials of an item do not contain natural rubber latex. FDA C106039 FDA CDRH GUDID Terminology C150161 Outer Diameter (OD) Crossing Profile|Distal Outer Diameter (OD)|Proximal Outer Diameter (OD) The nominal measure of the outer diameter of the the balloon. The nominal measure of the outer diameter of the the balloon. FDA C106039 FDA CDRH GUDID Terminology C124136 Outer/Greatest Diameter The greatest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The longest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the outer circumference. FDA C106039 FDA CDRH GUDID Terminology C54068 Over the Counter (OTC) Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC). A medicine or device that can be bought without a doctor's order or prescription. FDA C106039 FDA CDRH GUDID Terminology C101690 Ozone A sterilization process that uses radicals that form from ozone gas to kill microorganisms. A sterilization process that uses ozone gas to kill microorganisms. This process may be used on objects that cannot withstand high temperatures. FDA C106039 FDA CDRH GUDID Terminology C101699 Package DI Number A device identifier for the package configuration that contains multiple units of the base package (does not include shipping packages). The main identifier of a package type. FDA C106039 FDA CDRH GUDID Terminology C63850 Particle An object with finite mass and size parameters. FDA C106039 FDA CDRH GUDID Terminology C101697 Peracetic Acid A sterilization process that uses the vaporized form of a chemical (peracetic acid) to kill microorganisms. A sterilization process that uses the vaporized form of peracetic acid to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C112332 Pore Size A quantitative or qualitative measurement of the physical dimensions of the pores in a material. FDA C106039 FDA CDRH GUDID Terminology C80441 Premarket Approval A premarket submission made to FDA to review and evaluate the safety and effectiveness of a Class III medical device. FDA C106039 FDA CDRH GUDID Terminology C80442 Premarket Notification Stability data submitted for a premarket 510(k) submission. A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization). FDA C106039 FDA CDRH GUDID Terminology C28180 Prescription Use (Rx) Indicates that the device requires a prescription to use. A verbal or written order given by an authorized person instructing a patient to obtain and use a medical device, prescription or undergo a procedure. FDA C106039 FDA CDRH GUDID Terminology C25195 Pressure The force applied to a unit area of surface. The force applied to a unit area of surface. FDA C106039 FDA CDRH GUDID Terminology C125196 Previous Company Name Company previously responsible for labeling a medical device, prior to a merger or acquisition which required a change to the responsible party. The company that was formerly responsible for labeling a medical device. FDA C106039 FDA CDRH GUDID Terminology C125195 Previous Device Identifier Alternate device identifier assigned to a medical device before a change occurred that required the assignment of a new identifier. The identifier previously used to specify a medical device, prior to a change of the identifier. FDA C106039 FDA CDRH GUDID Terminology C101722 Primary DI Number The main identifier for a device. FDA C106039 FDA CDRH GUDID Terminology C70875 Product Development Protocol A regulatory plan or strategy submitted to the FDA proposing the approval of a new device for marketing in the U.S. It includes a demonstration of the safety and efficacy of the device. FDA C106039 FDA CDRH GUDID Terminology C101715 Radiation Sterilization A sterilization process that uses radiation such as electron beams, X-rays, gamma rays, or subatomic particles to kill microorganisms. A sterilization process that uses radiation such as electron beams, X-rays, gamma rays, or subatomic particles to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C150164 Rated Burst Pressure RBP Calculated pressure at which a balloon would not be expected to burst. Based on an appropriate confidence and reliability from measured burst pressures. (ISO 25539-2) Calculated pressure at which a balloon would not be expected to burst. Based on an appropriate confidence and reliability from measured burst pressures. FDA C106039 FDA CDRH GUDID Terminology C160942 Reduced Function A decrease in the functionality of a device. FDA C106039 FDA CDRH GUDID Terminology C160944 Reported in Error A report was made erroneously. FDA C106039 FDA CDRH GUDID Terminology C121676 RFID A system consisting of an implantable radiofrequency identification (RFID) tag and a hand-held radiofrequency reader to preoperatively mark breast lesions and later surgically retrieve them. FDA C106039 FDA CDRH GUDID Terminology C150244 Rotating Component Diameter The diameter of the rotating component of an atherectomy device. The diameter of the rotating component of an atherectomy device. FDA C106039 FDA CDRH GUDID Terminology C150243 Rotating Component Length The length of the rotating component of an atherectomy device. The length of the rotating component of an atherectomy device. FDA C106039 FDA CDRH GUDID Terminology C101724 Secondary DI Number An identifier that is an alternate (secondary) lookup for a medical device that is issued from a different issuing agency than the primary DI. An alternate identification number for a device. FDA C106039 FDA CDRH GUDID Terminology C74528 Self-reported An individual's perspective or subjective interpretation of an event or information. FDA C106039 FDA CDRH GUDID Terminology C101671 Serial Number Production Identifier The number assigned to individually identify a single unit or device. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. The production identifier is the serial number. FDA C106039 FDA CDRH GUDID Terminology C150142 Shaft length The length of the balloon catheter tube that extends from the catheter handle to the distal end of the catheter. The length of the balloon catheter tube that extends from the catheter handle to the distal end of the catheter. FDA C106039 FDA CDRH GUDID Terminology C101695 Sound Waves A sterilization process that uses high-frequency sound waves to kill microorganisms. A sterilization process that uses high-frequency sound waves to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C101704 Special Storage Conditions Any special storage requirements for this device. Specific conditions under which a device should be stored. FDA C106039 FDA CDRH GUDID Terminology C84382 Sterilization Method Validated process used to render product free from viable microorganisms. See ISO/TS 11139. A process for killing microorganisms. FDA C106039 FDA CDRH GUDID Terminology C101705 Storage Environment Atmospheric Pressure Storage requirements that are indicated for the device; atmospheric pressure under which the product should be stored, e.g., 1000 - 1100 hPa. The recommended storage atmospheric pressure for a device. FDA C106039 FDA CDRH GUDID Terminology C101706 Storage Environment Humidity Storage requirements that are indicated for the device; relative humidity in volume percent under which the product should be stored, e.g., 0 - 20 %. The recommended storage humidity level for a device. FDA C106039 FDA CDRH GUDID Terminology C101707 Storage Environment Temperature Storage requirements that are indicated for the device; environmental temperature range under which the device should be stored. The recommended storage temperature for a device. FDA C106039 FDA CDRH GUDID Terminology C107417 Supercritical Carbon Dioxide A sterilization process that uses supercritical carbon dioxide in combination with a small percentage of additive to kill microorganisms. A sterilization process that uses supercritical carbon dioxide to kill microorganisms. FDA C106039 FDA CDRH GUDID Terminology C70862 Supplement Number Additional documentary support presented to a regulatory agency to bolster a previous submission. FDA C106039 FDA CDRH GUDID Terminology C150194 Tapered Stent Larger Diameter The diameter of the portion of the tapered end of the stent that is the larger of the two tapered ends. The diameter of the portion of the tapered end of the stent that is the larger of the two tapered ends. FDA C106039 FDA CDRH GUDID Terminology C150196 Tapered Stent Length The length of the tapered portion of the stent. The length of the tapered portion of the stent. FDA C106039 FDA CDRH GUDID Terminology C150192 Tapered Stent Smaller Diameter Distal Stent|Tapered Stent Smallest Diameter The diameter of the portion of the tapered end of the stent that is the smaller of the two tapered ends. The diameter of the portion of the tapered end of the stent that is the smaller of the two tapered ends. FDA C106039 FDA CDRH GUDID Terminology C101710 Third Party The third party delegated by a manufacturer to submit regulatory information on behalf of a manufacturer of medical devices. An outside party delegated to submit regulatory information. FDA C106039 FDA CDRH GUDID Terminology C150187 Tip Bend Radius The radius of an imaginary circle drawn inside of a curve of a curved catheter or guidewire. The radius of an imaginary circle drawn inside of a curve of a curved catheter or guidewire. FDA C106039 FDA CDRH GUDID Terminology C25335 Total Volume The total amount of three dimensional space occupied by an object or the capacity of a space or container. The amount of three dimensional space occupied by an object or the capacity of a space or container. FDA C106039 FDA CDRH GUDID Terminology C160946 UDI Entry Type The method in which data was obtained about a device. FDA C106039 FDA CDRH GUDID Terminology C101696 Ultraviolet Light A sterilization process that uses short wavelength radiation to kill microorganisms. A sterilization process that uses short wavelength radiation to kill microorganisms. This process is used primarily in medical sanitation and sterile work facilities but also has applications for the sterilization of drinking water and waste water. FDA C106039 FDA CDRH GUDID Terminology C101717 Unit of Use Device Identifier An identifier assigned to associate the use of a device on a patient. This is for use when a UDI is not assigned to the individual device at the level of its Unit of Use. For example, a Unit of Use DI would be assigned to an individual electrode when the electrode is distributed in a package of 10. An identifier to associate the use of device on a patient when the Universal Device Identifier is applied to a package of multiple devices. FDA C106039 FDA CDRH GUDID Terminology C160945 Unknown The status of the device is unknown. FDA C106039 FDA CDRH GUDID Terminology C160948 Unknown The method of data entry is unknown. FDA C106039 FDA CDRH GUDID Terminology C25208 Weight The vertical force exerted by a mass as a result of gravity. The vertical force exerted by a mass as a result of gravity. FDA C106039 FDA CDRH GUDID Terminology C25345 Width The extent or measurement of something from side to side.