Device Dossier

Wound hydrogel dressing, sterile

Device Dossier for Wound hydrogel dressing, sterile (Wound hydrogel dressing, non-antimicrobial, Class IIb, sponsor Paul Hartmann). ARTG record, intended…

Intended purpose

For the treatment of chronic slow healing wounds where the granulation process is not functioning satisfactorily, eg leg ulcers, pressure sores, abscesses, boils, carbuncles. Also to treat superficial & second degree burns, to promote re-epithelialisation at split-skin graft donor sites after bleeding has stopped, and for wounds in trauma & tumour surgery which are difficult to manage. For superficial as well as deep and gaping wounds, acute and chronic as wellas clinically infected wounds.

TGA Public Summary