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Supply chain visibility helps you deliver traceability and transparency by providing unique identification information that trading partners and consumers rely on to make efficient and informed decisions, but this information is just as vital to increase patient and consumer safety.
To adequately identify medical devices sold in the United States, from manufacturing through distribution to patient use, the U.S. Food and Drug Administration (U.S. FDA) established the unique device identification (UDI) system.
As an accredited UDI issuing agency of the U.S. FDA, GS1 is required to identify companies that use or may use GS1 Standards for the assignment of UDIs. To meet this requirement, we are asking your company, irrespective of your business, to identify any GS1 Company Prefixes you have licensed with GS1 US that are or may be used to identify medical devices.
If a licensed GS1 Company Prefix (GCP) is currently used or may be used at any time to create a regulated unique identifier for medical devices (UDI), GS1 US:
Have any additional questions? Contact us at firstname.lastname@example.org.
Please fill out the below form and identify for each prefix licensed/owned by your company, if the prefix currently or could ever be used to identify medical devices. Please list only your GS1 Company Prefix. Global Trade Item Numbers will not be accepted.