bad17b75-18dd-401d-8195-d8106df1e482UpdatePublished22023-06-022022-02-28In Commercial DistributionD765CS0628PREM1PackageHIBCCD765CS0628PREM012In Commercial DistributionD765CS0628PREM0PrimaryHIBCCCytoplast™ PTFE SutureCS0628PREM123853058Osteogenics Biomedical Inc1Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 4-0, Precision Reverse Cutting 13 mm 3/8 Circle NeedlefalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse13909Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.trueActiveNBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneDevice Size Text, specify13mm 3/8 Circle RC NeedleDevice Size Text, specifyUSP 4-0 Suture RodLengthStorage Environment Temperaturetruefalse