Device Dossier

Medicine administration kit, percutaneous, medicated, single-use

Device Dossier for Medicine administration kit, percutaneous, medicated, single-use (Medicine administration kit, percutaneous, medicated, single-use,…

Intended purpose

Single use device for intracavernosal self-administration of medicine. It is for the treatment of erectile dysfunction in adult males. It may also be used as adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. The Caverject Procedure Pack is supplied with a vial containing Caverject powder for injection, a diluent syringe, needles and alcohol swabs. The Caverject Impulse Procedure Pack is supplied with a vial containing Caverject powder for injection, a diluent dual chamber cartridge, needles and alcohol swabs.

TGA Public Summary