Device Dossier
STRATAFIX Spiral MONOCRYL Unidirectional Plus Knotless Tissue Control Device - Barbed polyester suture, antimicrobial
Device Dossier for STRATAFIX Spiral MONOCRYL Unidirectional Plus Knotless Tissue Control Device - Barbed polyester suture, antimicrobial (Barbed…
- GMDN category: Barbed polyester suture, antimicrobial
Intended purpose
STRATAFIX™ Spiral Unidirectional MONOCRYL™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Functional description
A sterile, antibacterial monofilament, synthetic absorbable device composed of ≥ 99.95 weight percent copolymer of glycolide and ε-caprolactone. Device contains IRGACARE®‡ MP (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 μg/m. The device is available undyed and dyed to enhance visibility in the surgical field. The device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.