The device labeler must provide the UDI in two forms on labels and packages: Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.Date a specific device was manufactured.Lot or batch number within which a device was manufactured.Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:.Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.In most instances, the labeler is the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.Ī unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following: The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler. Submitting information to the GUDID databaseĪ labeler is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.Understanding exceptions, alternatives, and time extensions.

Meeting compliance dates and requirements.Developing a UDI using an FDA-accredited issuing agency’s system.

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