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Unique Device Identification (UDI) System for Medical Devices



Document Type:
A UDI unambiguously identifies a manufacturer’s specific medical device. A standardized UDI applied to the device or its label, documented in the UDI Database, and used consistently throughout distribution and use should facilitate a number of patient safety benefits, including: • traceability of devices, • the identification of devices in adverse events reports and other postmarket safety surveillance activities, • recalls and other field safety correction, and • reducing medical errors.

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