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-Device Identifier or UDI-DI
The DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements. If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent. The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. Taken from FDA Data Elements Reference Table - see


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