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Unique Device Identification Procedure

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The Unique Device Identification (UDI) Procedure governs the process of creating, submitting and maintaining Unique Device Identification (UDI) and BASIC UDI-DI codes for the FDA GUDID and EUDAMED database systems. The documentation addresses issuing agencies, UDI codes and database submissions.

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Unique Device Identification (UDI) Procedure Overview

The Unique Device Identification (UDI) Procedure is applicable to "Labelers" of all medical devices and applicable third party packagers labeling product on behalf of the manufacturer. The Unique Device Identification Procedure provides detailed instruction on UDI implementation planning, barcode format planning, Issuing Agency selection, and step by step FDA GUDID system data entry.

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