Device Dossier

Wound hydrogel dressing, non-sterile

Device Dossier for Wound hydrogel dressing, non-sterile (Wound hydrogel dressing, non-sterile, Class IIb, sponsor Te Arai BioFarma). ARTG record,…

Intended purpose

The wound hydrogel dressing is intended for use in the debridement and moistening of acute and chronic wounds, ulcers, cuts, abrasions, and burns. The hydrogel dressing is indicated to maintain the moisture thus establishing an optimum microenvironment for wound healing. Secondary antimicrobial effect achieved by the sodium chloride, sodium hypochlorite and hypochlorous acid is not due to pharmacological, immunological or metabolic means, but by physical process.

TGA Public Summary