C 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. C FDA C106039 FDA CDRH GUDID Terminology C150147 Nominal (Inflation) Pressure Balloon pressure at balloon nominal diameter condition. Balloon pressure at balloon nominal diameter condition. C 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. C 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. C 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. C FDA C106039 FDA CDRH GUDID Terminology C150184 Catheter Length The length of the catheter. The length of the catheter. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C 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. C FDA C106039 FDA CDRH GUDID Terminology C150371 Guidewire Length The length of the guidewire. The length of the guidewire. C FDA C106039 FDA CDRH GUDID Terminology C150372 Guidewire Diameter The diameter of the guidewire. The diameter of the guidewire. C 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. C 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. C 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. C FDA C106039 FDA CDRH GUDID Terminology C25333 Depth The extent downward or inward; the perpendicular measurement from the surface downward to determine deepness. C 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. C 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. C FDA C106039 FDA CDRH GUDID Terminology C25345 Width The extent or measurement of something from side to side. C 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. C 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. C FDA C106039 FDA CDRH GUDID Terminology C48161 Force The influence that produces a change in a physical quantity; physical energy or intensity. C 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. C FDA C106039 FDA CDRH GUDID Terminology C50021 Kit A collection of objects or devices collected together for a particular function or purpose. C 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). C 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. C 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. C 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). C 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. C 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. C FDA C106039 FDA CDRH GUDID Terminology C70862 Supplement Number Additional documentary support presented to a regulatory agency to bolster a previous submission. C 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. C 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. C 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). C FDA C106039 FDA CDRH GUDID Terminology C80438 Exempt Device A medical device that is exempt from FDA premarket notification requirements. C 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. C 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. C 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). C 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. C FDA C106039 FDA CDRH GUDID Terminology C99285 Model Number The identifier assigned to a particular design of a device. C 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. A 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. A FDA C106039 FDA CDRH GUDID Terminology C118639 Active (Implanted) An appliance or mechanism that continues to be implanted. A 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. A FDA C106039 FDA CDRH GUDID Terminology C122711 Malfunctioning A medical device that is functioning incorrectly. A FDA C106039 FDA CDRH GUDID Terminology C154407 Inactive Not progressing or moving. A FDA C106039 FDA CDRH GUDID Terminology C160938 Latex Safety A FDA C106039 FDA CDRH GUDID Terminology C160939 Device Implantable Status The status of the implantable device. A FDA C106039 FDA CDRH GUDID Terminology C160942 Reduced Function A decrease in the functionality of a device. A FDA C106039 FDA CDRH GUDID Terminology C160943 Device Status The current status of the device. A FDA C106039 FDA CDRH GUDID Terminology C160944 Reported in Error A report was made erroneously. A FDA C106039 FDA CDRH GUDID Terminology C160945 Unknown The status of the device is unknown. A FDA C106039 FDA CDRH GUDID Terminology C160946 UDI Entry Type The method in which data was obtained about a device. A FDA C106039 FDA CDRH GUDID Terminology C160947 Card A card which contains data for automatic processing of an item. A FDA C106039 FDA CDRH GUDID Terminology C160948 Unknown The method of data entry is unknown. A 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. A FDA C106039 FDA CDRH GUDID Terminology C43361 Barcode A machine-readable representation of information in a visual format on a surface. A FDA C106039 FDA CDRH GUDID Terminology C45329 Active Exerting influence or producing an effect. A FDA C106039 FDA CDRH GUDID Terminology C63850 Particle An object with finite mass and size parameters. A FDA C106039 FDA CDRH GUDID Terminology C74528 Self-reported An individual's perspective or subjective interpretation of an event or information.