Device Dossier

Exudate-absorbent dressing; non-gel

Device Dossier for Exudate-absorbent dressing; non-gel (Exudate-absorbent dressing, non-gel, Class IIb, sponsor Paul Hartmann). ARTG record, intended…

Intended purpose

The device is a sterile, non-medicated single-use polyurethane foam dressing with a three-dimensional foam structure which can effectively absorb wound exudate and maintain a moist wound environment. Indicated for medium to highly exuding, acute and chronic wounds, such as venous ulcers (leg ulcers), pressure ulcers II-IV, diabetic foot ulcers, donor sites, abrasions, incisions. It is intended to be used by lay persons and health care professionals.

TGA Public Summary