Device Dossier

Exudate-absorbent dressing, hydrophilic-gel

Device Dossier for Exudate-absorbent dressing, hydrophilic-gel (Exudate-absorbent dressing, hydrophilic-gel, Class IIb, sponsor Paul Hartmann). ARTG…

Intended purpose

The device is a sterile, single-use, non-invasive hydrocolloid dressing for use on intact and injured human skin by healthcare professionals. It can be used for treatment of medium to slightly exuding acute and chronic wounds, burns up to grade II or wounds at skin removal sites including heel, elbow and sacral area and for prevention of facial pressure injuries. Thin version can be used for treatment of slightly exuding wounds. The product can remain in place for up to 7 days. The accumulated use can exceed 30 days.

TGA Public Summary