Device Dossier
Skin semi-occlusive dressing
Device Dossier for Skin semi-occlusive dressing (Skin semi-occlusive dressing, Class IIa, sponsor Stratpharma). ARTG record, intended purpose, GMDN…
- GMDN category: Skin semi-occlusive dressing
Intended purpose
StrataXRT is intended for prevention and treatment of Radiation Dermatitis. StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation that lightly bonds to the most superficial skin layer, protecting the acid mantle of the skin, allowing optimal hydration and reducing the skin's acute inflammatory response seen with radiation dosing and first and second degree burns. When used as directed StrataXRT dries to form a protective flexible wound dressing that is gas permeable and waterproof which hydrates and protects toxic skin areas following radiation therapy