Nitinol Memory Alloy Surgical Suture
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Non-Absorbable Sutures
This disposable surgical suture is available in with or without needle configurations to meet diverse clinical requirements. The surgical suture with needle features a surgical needle made from medical-grade stainless steel (30Cr13) integrated with a suture made of premium nickel-titanium (nitinol) shape memory alloy wire. This assembly is complemented by an uncoated polypropylene (PP) retaining clip to ensure secure fixation. The nitinol memory alloy suture is ethylene oxide sterilized for single-use only, adhering to the highest safety standards to prevent cross-contamination.
Certificates of Qualification:
- ISO 13485 Certificate No.: C564964
- ISO 45001 Certificate No.: NOA2403088
- ISO 14001 Certificate No.: 00222E34558ROS
- China NMPA Registration No.: Lu National Medical Device Registration Permit No. 20262020117
Features
- The suture needle features a smooth and uniform surface finish with a precision-engineered tip, free of hooks. The needle hole and groove are centered and smooth without burrs or axial deviation. After integration with the suture, the needle attachment remains smooth and entirely free of sharp edges or burrs.
- The suture itself is featured by a smooth, uniform texture, free of stains and knots. For the suture with needle, the connection zone between the needle and the suture is seamlessly smooth.
- The suture length is strictly controlled, not exceeding 5.5m and maintaining a minimum of 95% of the indicated length.
- The surgical suture is supplied in a sterile state. The residual ethylene oxide content is strictly limited to ensuring patient safety: no more than 250 μg/g for the suture, and no more than 10 μg/g for both the needle and the fixation clip.
Advantages
- Provides continuous, adaptive compression upon tissue contact, ensuring better wound approximation and reducing scar formation.
- Excellent biocompatibility, visible under X-ray and MRI, and safe for MRI procedures with the suture in place.
- Ultra-smooth surface, easy suture removal, reducing patient discomfort and easing the workload of medical professionals.
| Size/USP | 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2, 3 |
| Length/cm | 2-5.5m |
| Needle Radian | 1/2 circle, 3/8 circle, 1/4 circle, 3/4 circle, straight, 1/8 circle, 5/8 circle |
| Needle Type | Round Bodied, Cutting, Reverse Cutting, Spatula, Taper Cutting, Blunt, Diamond, SKI Round Bodied, SKI Reverse Cutting, SKI Cutting |
| Needle Diameter×Chord Length (0.1mm×mm) | (0.1-18)×(2-500) |
Note: Needle diameter is indicated in units of 0.1mm (e.g., a designation of "6" represents a 0.6mm diameter).
How to Use
- Select the appropriate suture specification based on the specific clinical requirements of the surgical procedure.
- Check the packaging for integrity and ensure the product is within its valid expiration date before use.
- Take out the suture and the retaining clip from the packaging. Use the clip to secure the needle, positioning it at a point one-third (1/3) to one-half (1/2) of the distance from the needle tail to the tip to prevent damage to the needle.
- Before suturing, secure a retaining clip 2.0cm from the end of the suture. Perform continuous intradermal suturing following an S-shaped pattern. If twisting occurs during the procedure, straighten the suture before proceeding. After suturing, secure the suture end with another retaining clip and cut off the excess suture at a distance of 2.0cm from the clip.
- For suture removal, remove the retaining clips and use the clip to secure one end of the suture, pulling it out gently along the axis of the incision line.
Contraindications
- Contraindicated for patients with a known hypersensitivity to it. Use with caution in patients with allergic constitutions.
- This suture is indicated strictly for human skin closure and must not be used for suturing internal tissues or organs.
- For single use only, please do not use if the primary sterile packaging is damaged. Dispose of damaged products according to medical waste protocols.
- Do not use beyond the indicated expiration date.
- When handling the suture with forceps or needle holders, avoid squeezing or curling the suture. Mechanical deformation such as squeezing or curling may adversely affect the suture's tensile strength and performance.
Warnings and Reminders
- As this is a non-absorbable suture, it should typically be removed 7 days after wound closure, based on clinical assessment.
- Store in a well-ventilated indoor environment with temperatures below 25°C and relative humidity below 80%, away from corrosive gases. During transportation, protect the product from heavy pressure, direct sunlight, and exposure to rain.
Sterilization
- This suture has been sterilized with ethylene oxide, and cannot be sterilized again.