FDA Source Definition
NCIt Definition
The device is managed by date of manufacture; the date a specific device was manufactured.
The production identifier is the date of manufacture.
The device is managed by expiration date; the date, which appears on the label, by which the device must or should be used.
The production identifier is the expiration date.
The device is managed by serial number. This number can be found on the device label or packaging. The serial number is assigned by the labeler and should be specific to each device.
The production identifier is the serial number.
The device is managed by lot or batch number. This number can be found on the device label or packaging. Lot or Batch means one or more components or finished devices 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.
The production identifier is the lot or batch number.
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.
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.
The medical device is free from viable microorganisms. See ISO/TS 11139.
A device is packaged as being free of any living organisms.
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.
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.
The device is exempt from Direct Marking requirements under 21 CFR 801.50.
An indication that a device is exempt from direct marking requirements.
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.
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.
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.
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.
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.
The length of a straight line passing through the center of the inner open space or cavity of a tubular organ and connecting two points on the circumference.
The length of the diameter passing through the center of a hollow cavity or tubular organ.
A number representing the outer diameter of a hypodermic needle.
A number representing the outer diameter of a hypodermic needle.
A sterilization process that uses radicals that form from hydrogen peroxide to kill microorganisms.
A sterilization process that uses hydrogen peroxide to kill microorganisms.
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.
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.
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.
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.
A sterilization process that uses high-frequency sound waves to kill microorganisms.
A sterilization process that uses high-frequency sound waves to kill microorganisms.
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.
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 paracetic acid to kill microorganisms.
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.
The second 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 second longest possible length of a straight line passing through the center of a nearly circular or spheroid object that connects two points on the circumference.
Any special storage requirements for this device.
Specific conditions under which a device should be stored.
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.
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.
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.
A public-facing support contact for the Labeler company responsible to support the reported device.
Support contact information for a device labeler.
The third 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 third longest possible length of a straight line passing through the center of a nearly circular or spheroid object that connects two points on the circumference.
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.
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.
A sterilization process that uses ethylene oxide (EtO) gas to kill microorganisms.
A sterilization process that uses ethylene oxide gas to kill microorganisms.
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.
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.
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.
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.
The main identifier for a device.
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.
Natural rubber latex was not used as materials in the manufacture of the medical product and container. Only applicable to devices not subject to the requirements under 21 CFR 801.437.
The composition of the materials of an item do not contain natural rubber latex.
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.
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.
Magnetic Resonance Imaging (MRI) Safety indicates that sufficient testing has been conducted to characterize the behavior of the device in the magnetic resonance (MR) environment. See ASTM F2503.
An indicator that safety testing has been performed in a magnetic resonance imaging environment.
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.
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.
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
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.
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.
A sterilization process to kill microorganisms using a liquid sterilant.
A sterilization method that uses a disinfectant for a period of time to kill all microorganisms except small numbers of bacterial spores.
The device is managed by Donation Identification Number. This number can be found on the device label or packaging. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation.
A sequence of characters assigned to a device that can be found on the device label or the device packaging.
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.
The extent downward or inward; the perpendicular measurement from the surface downward to determine deepness.
The linear extent in space from one end of something to the other end, or the extent of something from beginning to end.
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.
The extent or measurement of something from side to side.
The vertical measurement or distance from the base to the top of an object; the vertical dimension of extension.
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.
A collection of objects or devices collected together for a particular function or purpose.
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).
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.
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.
The length of the closed curve of a circle; the size of something as given by the distance around it.
Additional documentary support presented to a regulatory agency to bolster a previous submission.
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.
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.
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).
A medical device that is exempt from FDA premarket notification requirements.
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.
A premarket submission made to FDA to review and evaluate the safety and effectiveness of a Class III medical device.
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).
Validated process used to render product free from viable microorganisms. See ISO/TS 11139.
A process for killing microorganisms.
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 circumference.
The identifier assigned to a particular design of a device.
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.