Global Unique Device Identification Database (GUDID)
Description
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).
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A UDI is composed of two parts:
- Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model.
- Production Identifier(s) (PI) - Numeric or alphanumeric codes that identify production information for a device and can include the following:
- The lot or batch number;
- The serial number;
- The expiration date;
- The date the device was manufactured;
- For a Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) regulated as a device, the distinct identification code that allows the manufacturer to associate the HCT/P to the donor.
Therefore, UDI = DI + PI.