Silk Suture 2-0 Reverse Cutting Needle

Description

1. Product Overview

The Silk Suture 2-0 with Reverse Cutting Needle is a premium, non-absorbable braided silk surgical suture indicated for soft tissue approximation and ligation across general surgery, ophthalmic, and cardiovascular procedures. Its primary industrial use lies in high-precision operating rooms and ambulatory surgical centers where tactile handling, knot security, and needle penetration control are critical. The key value proposition is its exceptional balance of low tissue drag and high tensile strength retention, enabling surgeons to perform interrupted or continuous suturing with reduced trauma. Strategically, this product is vital for global surgical supply chains because it meets ISO 10993 biocompatibility standards while offering a cost-efficient alternative to synthetic monofilaments in non-critical tension zones.

2. Key Specifications & Technical Characteristics

• Material Composition: Braided silk fibroin (natural protein filament), coated with a proprietary wax/silicone blend for reduced capillarity

• Purity/Grade: Medical Grade, USP Class I / EP 4.0 compliant; sterile, non-pyrogenic

• Physical Characteristics:

  • Size: USP 2-0 (metric 3.5)

  • Color: Black with traceable blue stripe (high visibility in surgical field)

  • Tensile strength: ≥ 8.9 N (knot-pull, dry)

  • Needle type: 3/8 circle, reverse cutting edge

  • Needle length: 26 mm – 30 mm

  • Suture length: 75 cm (standard)

• Packaging Options:

  • Individual peel-open sterile foil packs (1 suture/pack)

  • Carton of 12 packs (inner box)

  • Case of 144 packs (bulk OR pack)

• Shelf Life: 5 years from date of sterilization (ethylene oxide) when stored in controlled environment (15–25°C, <65% RH)

3. Core Industrial Applications

• Primary Industries: Acute care hospitals, veterinary surgical centers, dental/oral surgery clinics, and medical device distributors serving emerging markets.

• Specific Operational Use Cases:

  • General surgery: Ligating small-to-medium vessels, closing fascial layers

  • Ophthalmic surgery: Conjunctival closure and corneal limbal incisions

  • Cardiovascular access: Securing pacing leads or cannulation sites

• Performance Advantage: Unlike polypropylene or nylon, silk provides superior knot security (no slippage) and pliable handling for deep cavity work. The reverse cutting needle’s triangular tip with heel on the outer curvature cuts through tough tissue (e.g., skin, calcified vessels) while minimizing unintended lateral tearing compared to conventional cutting needles.

• Efficiency gain: 32% faster knot tying vs. monofilament sutures in simulated procedure tests; reduces OR time by ~4–6 minutes per closure case.

4. Competitive Advantages

• Quality Consistency: Lot-to-lot coefficient of variation for tensile strength <2.5% (n=300 tests). Each batch undergoes ISO 13485-certified sterility, endotoxin, and nickel content verification.

• Supply Reliability: Dual manufacturing sites (Asia and Europe) with 6-month safety stock buffer; lead time <14 days for standard packs.

• Logistics Capability: Pre-negotiated cold-chain optionality not required; ambient sea/air freight with breach-proof moisture barrier packaging.

• Price Competitiveness: 18–22% lower than Ethicon and Covidien equivalent codes (e.g., B512, SX1052) for identical USP 2-0 reverse-cutting specifications, without volume-based rebate locking.

• Sustainability & Technical Support: Packaging recyclable via TerraCycle® program; full IFU documents in 9 languages, plus online surgical technique videos accessible via QR code on each box.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): 3,600 units (25 inner cartons) for direct factory shipment

• BULK 20MT Loading Capacity:

  • 1 x 20’ container (dry van): 520,000 individual sterile sutures ≈ 3,611 inner cartons

  • Net weight per suture pack: ~8 g

  • Total bulk order: 20 MT ≈ 2.5 million units (mixed sizes allowed)

• Lead Time for Bulk Orders: 21 days after order confirmation and L/C validation

• Incoterms offered: FOB (Shanghai / Rotterdam) or CIF (major global ports)