Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)
The unique device identification (UDI) is a numeric or alphanumeric code related to a medical device. It allows the identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components:
- a device identifier (UDI-DI)
- a production identifier (UDI-PI)
These provide access to useful information about the device. The specificity of the UDI
- makes traceability of devices more efficient
- allows easier recall of devices
- combats counterfeiting
- improves patient safety
The UDI will be an addition to, not a substitute for, the existing labelling requirements for medical devices.
GUDID (the Global Unique Device Identification Database) is a central repository of detailed medical device information created by the Food and Drug Administration (FDA). The GUDID was implemented as a component of the FDA’s Unique Device Identifier (UDI) requirements and serves as a digital hub of all the UDI information for all the medical devices that are marketed in the USA.
The GUDID database is designed to help identify and trace all medical devices sold in the U.S. and provides detailed information about each device including manufacturer and production information, intended use, safety, and storage and handling requirements. The database is accessible to regulators, manufacturers, healthcare providers, insurers, and the public at large.
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