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GUDID Database — Submitting & Maintaining

What is GUDID?​

The GUDID (Global Unique Device Identification Database) is the FDA database containing information about each device identifier (DI). Manufacturers must submit DI records to GUDID before marketing a device with UDI labelling.

What must be submitted to GUDID​

For each Primary DI, the submitter must provide:

  • Brand name
  • Version or model number
  • Company name
  • Labeller DUNS number
  • Device description
  • Device class (I/II/III)
  • 510(k)/PMA/De Novo number
  • Whether the device is sterile, latex-free, implantable, or a single-use device
  • MRI safety information
  • Applicable standards

How to submit​

Submissions to GUDID can be made via:

  • GUDID Web Interface — manual entry through the FDA portal; or single submissions recommended manufacturers with or complex device standardized format and regulatory submissions suitable for small device portfolios
  • GUDID Bulk Upload — XML-based batch submission; for large portfolios
  • HL7 SPL (Structured Product Labelling) — for integration with enterprise systems

AccessGUDID — public search​

AccessGUDID (accessgudid.nlm.nih.gov) is the publicly searchable version of the GUDID, maintained by the National Library of Medicine. Anyone can search for device DI records.

Official resources​

What is GUDID?​

GUDID submissions must be completed before the device is commercially distributed or marketed in the United States. Failure to submit required information to GUDID before marketing can result in warning letters and enforcement action.