Device Dossier

Pty Ltd - Wound hydrogel dressing, sterile

Device Dossier for Pty Ltd - Wound hydrogel dressing, sterile (Wound hydrogel dressing, non-antimicrobial, Class IIb, sponsor Paragon Care). ARTG record,…

Intended purpose

A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing). This is a single-use device.

TGA Public Summary