Implementation Guideline for U.S. FDA Unique Device Identification (UDI)

This implementation guideline was prepared by GS1 Healthcare US to assist suppliers and receivers of medical devices in the U.S. to implement the U.S. FDA UDI Rule using GS1 Standards. This guideline is based on the GS1 General Specifications, and was developed using information obtained from all members of the U.S. healthcare supply chain, from manufacturers to providers.

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