5a7f8f6a-dce0-474f-9def-719412abe332UpdatePublished62025-08-182017-02-13In Commercial DistributionB05502280SLPrimaryHIBCCX-RepairSLZ022-80SL140697280SYNTHASOME, INC.1X-RepairSL, Bioabsorbable surgical mesh, single layer, 12mm x 80mm (WxL)falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse858-490-9400xxx@xx.xxK14149900044688Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn 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.trueActiveFTLMesh, Surgical, PolymericLengthWidthtruefalse