Understanding GUDID for Medical Device Labelers
The GUDID (Global Unique Device Identification Database) is the FDA's official database for medical device identification in the U.S. GUDID supports compliance, transparency, and traceability across the entire product lifecycle.
What GUDID Includes
- Device Identifier (DI): Identifies the labeler and device model.
- Device name, brand, and catalog number.
- FDA product code and GMDN term.
- Packaging configurations.
- Production Identifier (PI) flags (e.g., lot number, serial number, and expiration date indicators).
GUDID does not store confidential design data or actual serial numbers—only standardized device information.
Labeler Responsibilities in GUDID
- Obtain a UDI from an FDA-accredited issuing agency.
- Create and publish Device Identifier (DI) records in GUDID.
- Maintain accurate GUDID data.
- Update records within 10 business days when changes occur.
Effective GUDID management ensures regulatory compliance, patient safety, and reliable medical device traceability.