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 (lot, serial number, expiration date indicator)

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 agency
• Create and publish DI records in GUDID
• Maintain accurate GUDID data
• Update records within 10 business days if changes occur

Effective GUDID management ensures regulatory compliance, patient safety, and reliable medical device traceability.