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Across the supply chain, unique product identification is the basis for efficiency and visibility. This identification is even more imperative when it comes to healthcare products, like medical devices, to help increase patient and consumer safety. That is why the U.S. Food and Drug Administration (U.S. FDA) established the unique device identification (UDI) system to adequately identify medical devices sold in the United States.
The U.S. FDA is requiring the identification of all GS1 Company Prefixes that are or may be used to identify medical devices. This identification is required to help the U.S. FDA and the entire supply chain increase patient and consumer safety by tracking medical devices from manufacturing through distribution to patient use.
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 email@example.com.
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.