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510(k) Data Aggregation
Device Name
Derma-GideManufacturer
Date Cleared
2026-03-19
(30 days)
Product Code
Regulation Number
N/AType
SpecialAge Range
All
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Derma-Gide is intended for the management of wounds including:
- partial and full thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
- trauma skin wounds (abrasions, laceration, partial thickness second degree burns, skin tears)
Device Description
Derma-Gide is a sterile, single-use only, acellular advanced wound care device primarily derived from porcine collagen. Derma-Gide features a bilayer structure. The upper dense compact collagen layer protects the wound. This structure has a smooth texture with appropriate pull-out strength properties to allow suturing. The second lower layer consists of a thick, porous spongeous collagen scaffold.
Derma-Gide is provided in rectangular and round shapes in multiple sizes/diameters.
AI/ML Overview
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