Wound Covering (Composite Cultured Skin)
- US Product Code (FDA)
- ODSView Product Code Classification →
- US Risk Class (FDA)
- Class f
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Wound covering. Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities).
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Wound Covering (Composite Cultured Skin) is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.