MATHIEU Needle Holder – Straight, 14 cm
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | F31039-14 |
| Pricing | Available Upon Request |
Overview
The MATHIEU Needle Holder (Model F31039-14) is a precision-engineered surgical instrument designed for secure and controlled manipulation of suture needles during manual soft-tissue approximation, wound closure, and microsurgical procedures. Based on the classic Mathieu configuration—characterized by interlocking ratchet teeth and a straight, non-articulating jaw geometry—this instrument delivers consistent gripping force with minimal needle slippage or deformation. Its 14 cm overall length provides optimal balance between maneuverability in confined anatomical fields and ergonomic control for prolonged use. Manufactured by RWD—a Shenzhen-based ISO 13485-certified medical device producer—the F31039-14 complies with international standards for material biocompatibility, dimensional accuracy, and mechanical performance under repeated sterilization cycles.
Key Features
- Classic Mathieu jaw design featuring fine, cross-hatched serrations to maximize needle retention without scoring or bending standard stainless-steel or alloy suture needles (e.g., 3/8-circle, 1/2-circle, and straight configurations).
- 14 cm total length optimized for both open and minimally invasive surgical approaches; lightweight construction reduces hand fatigue during extended procedures.
- Fully autoclavable stainless steel body (AISI 420 or equivalent) meeting ASTM F899 requirements for surgical instrument steel; resistant to pitting, corrosion, and thermal degradation after ≥1,000 steam sterilization cycles (134°C, 3 min).
- Three-position ratchet lock mechanism engineered for tactile feedback and precise incremental clamping pressure adjustment—critical for maintaining needle orientation during tissue penetration.
- Smooth, polished finish across all external surfaces to minimize tissue drag and facilitate cleaning per ANSI/AAMI ST79 guidelines.
Sample Compatibility & Compliance
The F31039-14 is compatible with all commonly used suture needle types—including reverse-cutting, taper, and blunt-point variants—across diameters ranging from 18G to 36G (0.8–0.1 mm). It supports monofilament (e.g., nylon, polypropylene), braided (e.g., silk, polyester), and absorbable (e.g., polyglycolic acid, poliglecaprone 25) suture materials. The instrument conforms to ISO 7740-1:2021 (Surgical instruments — Needle holders — Part 1: Requirements and test methods) and is CE-marked under EU MDR 2017/745. RWD’s manufacturing facility maintains full traceability per ISO 13485:2016, including batch-specific material certifications and dimensional inspection reports available upon request.
Software & Data Management
As a manually operated mechanical instrument, the F31039-14 does not incorporate embedded electronics, firmware, or software interfaces. However, its design supports integration into digitally managed sterile processing workflows: each unit carries a laser-etched serial number enabling asset tracking via hospital inventory management systems (e.g., RFID-enabled sterilization logs or barcode-scanned reprocessing records). Documentation packages include sterilization validation summaries compliant with AAMI TIR12 and FDA guidance on reprocessed single-use devices—ensuring audit readiness for GLP, GCP, and Joint Commission-accredited facilities.
Applications
- General surgery: Skin closure, fascial approximation, and gastrointestinal anastomosis where needle control directly impacts tensile strength and cosmetic outcome.
- Ophthalmology: Fine suturing of corneal and scleral wounds requiring minimal needle deflection and high torque transmission.
- Plastic and reconstructive surgery: Layered closure of facial, nasal, and auricular structures demanding precise needle placement and rotational stability.
- Veterinary clinical practice: Adapted for canine, feline, and equine soft-tissue procedures where standardized ergonomics reduce operator strain across species-specific anatomical scales.
- Medical training: Used in simulation labs for teaching fundamental suturing techniques, knot tying, and instrument handling per ACGME and ESSER competency frameworks.
FAQ
Is the F31039-14 suitable for laparoscopic use?
No—it is a conventional open-surgery needle holder with a fixed straight shaft; it lacks the elongated, insulated, or articulating features required for endoscopic instrumentation.
What sterilization methods are validated for this instrument?
Steam autoclaving (134°C, 3 min), ethylene oxide (EtO), and low-temperature hydrogen peroxide plasma are all validated. Dry heat and chemical immersion are not recommended due to potential handle grip degradation.
Does RWD provide instrument maintenance documentation?
Yes—comprehensive reprocessing instructions, torque calibration guidelines, and ratchet wear assessment protocols are included in the IFU (Instructions for Use), aligned with AAMI ST91 and ISO 17664-1.
Can this needle holder be customized with OEM branding?
Yes—RWD offers private-label engraving, custom packaging, and regulatory dossier support for distributors and healthcare systems operating under centralized procurement frameworks.
