Device typeDermal tissue reconstructive material, animal-derived: A sterile, bioabsorbable, animal-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), to correct cutaneous contour deformities (e.g., scars) associated with aging, injury, or degenerative lesions; it may in addition be used as a bulking material for incontinence treatment (e.g., in the urinary tract). It does not include a local anaesthetic agent. It includes animal-derived collagen or hyaluronic acid (HA) [e.g., porcine, bovine]. It is typically preloaded in a disposable syringe.
FDA categoryImplant, Dermal, For Aesthetic Use
Device ID00350224000141
Catalog numberGBF0115, GBF0215, GBF0315
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information