Product Description
Covidien S195 – Suture 2-0 Silk No Needle Sofsilk Black 18″ Braid 24/Bx
S195: 2-0 SOFSILK BLACK 12 X 18″ STRANDS (12 STRANDS PER PACKET) (WAX COATED)
Sofsilk sutures are non-absorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. The braided sutures are available coated uniformly with either silicone or a special wax mixture to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. The manufacturing process, from braiding to coating, gives the suture superior softness and compliance for maximum surgical handling. The proprietary coating process provides smooth flow through tissue while maintaining optimal knot security.
Sofsilk sutures are for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery, and neurological surgery.
PRE-CUT SUTURE – S195 Sofsilk 2-0 Black 12×18″
Sofsilk reverse cutting needles feature tri-coined, reverse cutting edges for use in dense connective tissue and skin. The cutting edge is on the convex surface of the needle arc, facilitating needle passage while minimizing tissue cut-through. Premium reverse cutting needles are made exclusively of Surgalloy material for added strength and ductility.
| Product No. |
Absorption Profile |
Length |
Color |
USP |
Metric |
Units Per Box |
| S195 |
Permanent |
RACETRAC 12×18″ |
Black |
2-0 |
1.5 |
24 |
Characteristics
The manufacturing process, from braiding to coating, gives the suture superior softness and compliance for maximum surgical handling. The proprietary coating process provides smooth flow through tissue while maintaining optimal knot security.
Indications
SILKsutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Contraindications
The use of this suture is contraindicated in patients with known sensitivities or allergies to silk. Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, SILKsutures should not be used where permanent retention of tensile strength is required.
Actions
SILKsutures elicit a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue.
Tensile Strength
While SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in vivo may result in gradual loss of tensile strength over time.
Packaging
SILK sutures are available white or colored black with Logwood extract and uniformly coated with silicone or wax, in USP and EP sizes 5 (7 metric) and 2 (5 metric) through 8-0 (0.4 metric). The sutures are supplied sterile, in pre-cut lengths and ligating reels, non-needled or affixed to needles using both permanent and removable needle attachment techniques; in one, two and three dozen box quantities.
Frequently asked questions
1. Questions: Can the Sofsilk reel, if left inside the body, be picked up by an x-ray?
Answers: Yes. The plastic suture reels are manufactured with a material molded into the plastic to allow location within the body by X-ray.
2. Questions: Are all Sofsilk sutures wax coated?
Answers: No, USP sizes 2 through 5/0 Sofsilk sutures are coated with wax and sizes 6/0 through 8/0 are coated with silicone.
Device Characteristics
| What MRI safety information does the labeling contain? |
Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): |
No |
| Device labeled as “Not made with natural rubber latex”: |
No |
| For Single-Use: |
Yes |
| Prescription Use (Rx): |
Yes |
| Over the Counter (OTC): |
No |
| Kit: |
No |
| Combination Product: |
No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): |
No |
