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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. Download the tool below (Version 1.0 xlsx 28kB):


For documents on ISBT 128 and on UDI, visit the Medical Devices subject area by clicking on the button below.

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