A unique numeric or alphanumeric code that consists of a device identifier (DI) and a production identifier (PI).

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 https://www.fda.gov/media/88408/download


Log in or register to post comments