Non-Absorbable Suture F34001-01 (Size 1, 0.45 mm Diameter)

Overview

The RWD Non-Absorbable Suture F34001-01 is a sterile, monofilament surgical suture engineered for long-term tensile strength retention and minimal tissue reactivity. Designed in accordance with ISO 10993–biocompatibility standards, this suture is manufactured from high-purity polypropylene—a synthetic polymer known for its excellent resistance to enzymatic degradation, low capillarity, and smooth surface finish. Unlike absorbable sutures that undergo hydrolytic or enzymatic breakdown over time, the F34001-01 maintains structural integrity indefinitely, making it suitable for applications where permanent mechanical support or prolonged wound approximation is clinically indicated. Its standardized USP size 1 designation corresponds to a nominal diameter of 0.45 mm, ensuring compatibility with common needle configurations and tissue handling protocols across general surgery, cardiovascular procedures, and ophthalmic closures.

Key Features

• Monofilament construction minimizes bacterial adherence and reduces tissue drag during passage.
• High tensile strength (>100 N for size 1) with consistent elongation profile (<20% at break), supporting secure knot security and resistance to slippage.
• Gamma-irradiated sterilization (25–35 kGy) validated per ISO 11137, with full sterility assurance (SAL 10⁻⁶) and documented bioburden control.
• Smooth surface finish achieved via precision extrusion and post-processing polishing—reducing friction coefficient and enhancing passage through dense or fibrous tissues.
• Compliant with ISO 8536–4 (sterile medical devices—sutures) and meets requirements for USP Class VI biological safety testing.

Sample Compatibility & Compliance

This suture is supplied in individually sealed, peel-open pouches containing pre-attached needles (needle type and curvature specified per order). It demonstrates compatibility with standard suture packaging materials (Tyvek®/polyethylene laminates) and remains stable under ambient storage conditions (15–30°C, ≤60% RH) for up to 5 years from manufacture date. All batches undergo rigorous quality control including dimensional verification (diameter tolerance ±0.02 mm), tensile testing per ASTM D2256, and dye penetration assessment for surface defects. Documentation supports traceability to raw material lot, sterilization cycle log, and final inspection records—fully aligned with ISO 13485:2016 quality management system requirements for medical device manufacturers.

Software & Data Management

As a passive medical device, the F34001-01 does not incorporate embedded electronics or require software interaction. However, RWD provides comprehensive digital documentation packages—including Certificates of Conformance, Sterilization Validation Reports, and Material Safety Data Summaries—accessible via secure customer portal upon registration. Batch-level data is structured to support integration into hospital inventory management systems (e.g., GS1-compliant barcoding) and electronic health record (EHR) procurement modules. For facilities operating under FDA 21 CFR Part 11 or EU MDR Annex II requirements, RWD supplies audit-ready documentation packages with electronic signature validation and version-controlled revision history.

Applications

• Cardiovascular surgery: Anastomotic reinforcement and prosthetic graft fixation where chronic mechanical load-bearing is required.
• Ophthalmology: Scleral buckling procedures and corneal transplant suturing demanding predictable handling and minimal inflammation.
• Dermatology and plastic surgery: High-tension wound closure on scalp, trunk, or extremities where cosmetic outcome depends on suture stability over extended healing periods.
• Orthopedic soft-tissue repair: Tendon-to-bone reattachment and ligament reconstruction requiring sustained tensile integrity during rehabilitation.
• Veterinary surgical use: Approved for companion animal procedures under veterinary oversight per national regulatory frameworks (e.g., CVMA guidelines).

FAQ

Is the F34001-01 suture MRI-compatible?
Yes. Polypropylene is non-ferromagnetic and exhibits no significant artifact or heating effect under standard clinical MRI field strengths (up to 3.0 Tesla), as confirmed by ASTM F2503 testing.

What needle options are available with this suture?
RWD offers customizable needle configurations including reverse-cutting, taper, and spatula tips—available in lengths from 12 mm to 40 mm and curvatures ranging from 1/4 to 5/8 circle. Needle-suture combinations are validated for pull-out strength per ISO 7198.

Does this product comply with USP General Chapter <788> particulate matter requirements?
Yes. Each production lot undergoes particulate analysis per USP <788> using light obscuration methodology, with limits set at ≤6000 particles ≥10 µm and ≤600 particles ≥25 µm per container.

Can this suture be resterilized if the package is compromised?
No. The product is supplied as single-use, terminally sterilized. Reprocessing is not recommended and voids compliance with ISO 17664 and AAMI ST79 guidelines.