Regulatory Contact's Information
Individual responsible for GUDID submission requirements for the labelers included in this GUDID account request.
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.
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)