Unique Device Identifier (UDI) Generator

The UDI Generator allows a user to create an ISBT 128 UDI for HCT/P medical devices. The program generates the UDI based on prompted entries of elements of the device identifier and production identifiers. Note: It is still the user's responsibility to check that the correct data has been entered into each field and to verify the UDI data string.

Intended Audience:
This tool is intended for US tissue banks or cellular therapy facilities that produce human cells, tissues, and cellular and tissue-based products (HCT/P) that are regulated as medical devices by the FDA. The tool may also be of use to software developers and label vendors that provide products for these facilities.

Version 1.0: Unique Device Identifier (UDI) Generator – xlsx (28 kB)


For information on ISBT 128 and UDI, visit the Medical Devices subject area.