Device Dossier

BIOBRANE Temporary Biosynthetic Wound Dressing - Dressing, occlusive, collagen

Device Dossier for BIOBRANE Temporary Biosynthetic Wound Dressing - Dressing, occlusive, collagen (Dressing, occlusive, collagen, Class III, sponsor…

Intended purpose

BIOBRANE Dressings are indicated for: • Covering clean partial thickness burn wounds • Split thickness donor sites

Functional description

BIOBRANE is a biosynthetic dressing made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted trifilament nylon fabric. Denatured porcine dermal collagen has been bonded to the nylon/silicone membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.

TGA Public Summary