FDA Unique Device Identifier (UDI) System

The FDA Unique Device Identifier (UDI) system requires medical devices to carry a unique identifier that allows them to be adequately identified through distribution and use. The UDI must appear on the device label and packaging, and device information must be submitted to the FDA's Global Unique Device Identification Database (GUDID).

UDI Components

A UDI consists of two parts: the Device Identifier (DI), a mandatory, fixed portion that identifies the labeler and the specific version or model of a device; and the Production Identifier (PI), a conditional, variable portion that identifies one or more of: the lot or batch number, the serial number, the manufacturing date, the expiration date, and the distinct identification code for a human cell, tissue, or cellular or tissue-based product.

GUDID Database

The Global Unique Device Identification Database (GUDID) is FDA's publicly accessible database of UDI information. Device labelers must submit device information to GUDID before placing a device on the US market. GUDID contains information about the device, its packaging, and the labeler.