Peripheral guidewire Singclean®

Product Name
Singclean® Peripheral Nerve Guide

Specification
Available sizes: 2 mm × 10 mm, 3 mm × 10 mm, 4 mm × 10 mm, 5 mm × 10 mm, 6 mm × 10 mm (inner diameter × length)

Description
The Singclean® peripheral nerve guide is a single‑use, hollow tubular conduit manufactured from chitin‑derived chitosan (acetylated). Each conduit is preserved in Water for Injection, packaged in aluminum foil pouches and sterilized by steam. Designed to provide a protective pathway for axonal regeneration in peripheral nerve repair.

Product Performance

• Appearance: White to pale yellow tubular structure with a clean surface free from foreign contaminants; no cracks, spots or tearing.
• Dimensional tolerance: Inner diameter and overall length within ±10% of labelled specification; tube wall thickness 0.5 mm–2.0 mm.
• Bacterial endotoxin: <5 EU per unit.

Indications
This product is indicated for the repair of peripheral nerve defects with a gap length not exceeding 20 mm.

Contraindications

• Severe decompensated cardiac, pulmonary, hepatic or renal dysfunction.
• Cachexia from chronic consumptive disease that contraindicates surgery.
• Pathological peripheral nerve conditions (non-traumatic neuropathies).
• Acute or chronic local infection adjacent to the target nerve.
• Long-segment nerve defects exceeding the applicable length.
• Infants, children, adolescents, pregnant women and patients planning pregnancy within 12 months postoperatively.
• Known hypersensitivity to chitin/chitosan materials.

Treatment Procedure

• Identify proximal and distal nerve stumps under microscopy or direct vision.
• Use appropriate microsutures (USP 6-0/7-0/8-0) for epineurial fixation: place sutures 2 mm from the conduit rim (outside‑in) to the epineurium 2 mm from the nerve transection; limit stitch depth to epineurium to avoid fascicular injury. Place two sutures separated by 180° on each stump (four sutures total).
• Insert proximal and distal nerve stumps 2 mm into the conduit lumen, maintaining an intraluminal gap ≤ 2 mm. Ensure conduit is tension‑free and prevent stump rotation.
• Secure sutures with appropriate knot technique.
• Postoperative immobilization of adjacent joints (e.g., cast or orthosis) for approximately 3 weeks is recommended per standard nerve repair protocols.

Precautions

• Device intended for use by trained medical professionals only.
• Fully mobilize nerve stumps prior to implantation and select conduit size and suture specifications based on intraoperative anatomy.
• Ensure gap between nerve stumps inside the conduit does not exceed 2 mm.
• Fix conduit without tension; apply postoperative immobilization as standard adjunct care.

Adverse Reactions
Potential adverse events include local inflammatory responses, hypersensitivity reactions, implant‑related pain or discomfort, surgical site infection, anesthesia‑related complications and risk of conduit rupture after implantation.

Storage
Store at ambient room temperature. Manufacturing date and expiry date are indicated on the package.

Shelf Life
24 months.

Regulatory / Document Info
Product code: 8.300.04.0011-A0
Issue date: 2026.07.07

Technical specifications

• Brand: Singclean
• Material: Chitin‑derived chitosan (acetylated)
• Configuration: Hollow tubular conduit
• Available sizes (inner diameter × length): 2×10 mm, 3×10 mm, 4×10 mm, 5×10 mm, 6×10 mm
• Tube wall thickness: 0.5 mm–2.0 mm
• Dimensional tolerance: ±10% for inner diameter and overall length
• Bacterial endotoxin limit: <5 EU per unit
• Sterilization: Steam sterilized
• Packaging: Preserved in Water for Injection; aluminum foil pouches
• Intended use: Repair of peripheral nerve defects up to 20 mm in length
• Single use only
• Storage: Ambient room temperature
• Shelf life: 24 months