Device typeExtra-gynaecological surgical mesh, synthetic polymer, bioabsorbable: An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.
FDA categoryPericardial Patch To Facilitate Revision Surgeries
Device ID00810057380266
Catalog number36504-01
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size130mm x 200mm x 0.05mm