Device Dossier

Needle, injector, medication/vaccine

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

Intended purpose

For the administration of Ovaleap from a cartridge in one of 3 strengths (300IU/450IU or 900IU). The procedure pack also contains either 10 needles (300IU and 450IU packs) or 20 needles (900IU pack). For use with the Ovaleap Pen.

TGA Public Summary