FDA UDI Help Desk | FDA

Request a GUDID Account

If you have questions related to UDI and GUDID, complete the following information to submit your question to the FDA UDI Help Desk.

Labelers of all classes of medical devices currently marketed in the United States may obtain a GUDID account.

All fields that begin with (red) asterisks are required.

Requester's Information

Regulatory Contact's Information

Individual responsible for GUDID submission requirements for the labelers included in this GUDID account request.

Organization's Information

FDA Premarket Number

* Please provide one valid FDA Premarket Number (PMA, 510k, etc.) for a device currently marketed in the U.S.

Device Identifier Prefix

Work with an FDA-accredited issuing Agency to obtain a prefix (Company Prefix, Labeler Identification Code (LIC), or Facility identification Number (FIN)) that will be used to construct your Device Identifiers.
GS1 Numbers need to be 6-14 digits long; HIBCC Numbers start with a letter and are followed by three digits; ICCBBA numbers use numbers and digits and are 10 to 16 characters long

Labeler DUNS Number

The labeler Duns number identifies the labeler for a version or model of a device. Each DI record must be associated with a labeler DUNS. The labeler name for a given DI record will be retrieved from the DUNS database based on the DUNS number entered for that DI record. The Labeler DUNS names should match the label for the corresponding device. The primary intent of using multiple Labeler DUNS is to have Labeler DUNS numbers in GUDID whose company name and address match what is on the device label. We will add multiple Labeler DUNS if you have a business need for them.
If you have more than one, please submit a .csv file via the upload files button.

Coordinator Information

Individual(s) responsible for management for the GUDID account for the designated Labeler DUNS; Please include the Labeler DUNS that is the responsibility of the Coordinator in the form below. If responsible for all Labeler DUNS accounts, please enter "ALL". If you have more than one, please submit a .csv file via the 'Upload Files' button

Third Party Submitter Information (if applicable)

Company/individual (contractor/vendor) authorized to submit GUDID information on behalf of the labeler.

Additional Information (if applicable)


For all technical questions relating to setting up or accessing your GUDID account, please contact the FDA UDI Help Desk.

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