Unique device identifier (UDI)

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. A unique device identifier is composed of:

A production identifier—a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

Source

21 CFR § 821.3

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Scoping language

The following definitions and terms apply to this part:

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