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-Lot or UDI-PI-Lot
The number assigned to one or more device(s) that consists of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Taken from FDA Data Elements Reference Table - see


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