There are a variety of reasons manufacturers put PIs on device labels and packages (e.g., to support their
own product tracking strategies; to comply with other regulatory requirements; etc.). The U.S. FDA UDI
Rule does not require any specific PIs. It simply requires that whatever PI(s) appear on the device label or
package (for whatever reason) must also be included in the UDI. Consult with your regulatory compliance
and/or quality teams to decide what PI(s) (if any) should be used on your device(s).
