Device Dossier

Dressing, wound-nonadherent, absorbent

Device Dossier for Dressing, wound-nonadherent, absorbent (Dressing, wound-nonadherent, absorbent, Class IIb, sponsor Emergo). ARTG record, intended…

Intended purpose

Silicone foam dressings with or without borders are indicated for mild, moderate, or highly exuding wounds, especially for the hard to dress area, such as leg and foot ulcers, pressure ulcers, and traumatic wounds (e.g. abrasions, cuts, finger injuries, blisters, skin tears and secondary healing wounds). Can be used for second-degree burns, donor sites, post-operative wounds and skin abrasions, under compression, graft and donor sites and for protection of compromised and/or fragile skin, and partial thickness burns. It is possible to be used continuously more than 30 days (The usage of the device can be discontinued in order for the device to be replaced immediately by the same device this shall be considered an extension of the continuous use of the device. 30 days was defined based on this principle).

TGA Public Summary