Product code OMD

Device name
Cutaneous Tissue Adhesive With Mesh
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4011
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset