Device Dossier

Needle, injector, medication/vaccine

Device Dossier for Needle, injector, medication/vaccine (Needle, injector, medication/vaccine, Class IIa, sponsor Embecta). ARTG record, intended…

Intended purpose

BD AutoShield Duo™ Safety Pen Needles are intended for use with pen injector devices for the injection of drugs by health care professionals or laypersons, in a hospital or home setting. The device is a single use sterile needle designed to reduce occurrence of accidental needle sticks from both ends of the needle by providing two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end).

TGA Public Summary