Unique Identification of Medical Devices
Learn how GS1 Standards can help your company
The U.S. FDA Unique Device Identification (UDI) Rule* establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device. UDIs will be presented on device labels in both a human-readable format and a machine-readable format (e.g., a barcode).
GS1 Standards can be used to support your UDI implementation for all Classes of medical devices.
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Resources for Healthcare Providers
Are you a Healthcare Provider and looking for education and implementation resources? If so, please visit www.gs1us.org/HealthcareProviders to learn how GS1 Standards can help your organization modernize its supply chain, improve patient safety, and reduce costs.
*For information about the rule, see the U.S. FDA Unique Device Identification System
Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.
GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.