An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.

Data Element

Information from the submission form

UDI-Production Identifier-Distinct Identification Code or UDI-PI-DIC
The Distince Identification code (aka Donation Identification Number (DIN)) is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. Taken from FDA Data Elements Reference Table - see


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