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510(k) Data Aggregation
(66 days)
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is a sterile synthetic absorbable monofilament suture composed of a copolymer of glycolide and (epsilon) ε-caprolactone. The empirical molecular formula of the polymer is (C2H2O2)m(C6H10O2)n.
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture is available undyed and dyed with D&C Violet #2
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture contains Triclosan, a broad spectrum antibacterial agent, ranging between 77 – 2360 μg of Triclosan per meter of suture. The maximum of 2360 μg/m falls well below literature values for toxicity of Triclosan based on a single worst-case dose. The lower specification limit is set at a value where claims for in-vitro antibacterial activity can be supported across all product variants throughout their shelf-life.
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