FDA product code OMD

Cutaneous Tissue Adhesive With Mesh

General, Plastic Surgery·Class 2·21 CFR 878.4011
US regulatory classifications
US Product Code (FDA)
OMD
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4011
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.

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About this record

Cutaneous Tissue Adhesive With Mesh is a medical device type in the General, Plastic Surgery 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.

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.