CRILE-WOOD Needle Holder – Straight, 15 cm & 16 cm (RWD F31029-15 / F31030-16)
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | OEM/ODM Manufacturer |
| Country of Origin | China |
| Model Numbers | F31029-15 (15 cm), F31030-16 (16 cm) |
| Pricing | Available Upon Request |
Overview
The CRILE-WOOD Needle Holder is a precision surgical instrument engineered for secure needle manipulation during suturing procedures in general surgery, ophthalmology, plastic surgery, and veterinary applications. Designed according to the classical Crile–Wood configuration—characterized by straight jaws with cross-hatched serrated tips and a ratchet-locking mechanism—the instrument provides optimal grip, torque transmission, and tactile feedback without damaging suture material or needle surfaces. Its ergonomic handle geometry minimizes hand fatigue during prolonged use, while the stainless steel construction ensures compatibility with standard autoclaving cycles (134 °C, 2 bar, 18 min) and repeated sterilization without degradation of mechanical integrity.
Key Features
- Two standardized lengths: 150 mm (F31029-15) and 160 mm (F31030-16), optimized for depth control and access in both open and minimally invasive surgical fields.
- High-grade austenitic stainless steel (AISI 304/316 equivalent), passivated per ASTM A967, delivering corrosion resistance, non-magnetic properties, and biocompatibility compliant with ISO 7153-1.
- Micro-serrated jaw surface (serration pitch: ~0.15 mm) engineered to maximize coefficient of static friction against stainless steel, tungsten carbide, and polymer-coated needles—reducing slippage during tissue approximation.
- Four-position ratchet lock with positive tactile and audible feedback, enabling precise incremental closure force adjustment and stable retention under lateral loading.
- Smooth, knurled handle surface with finger grooves conforming to EN 14233 anthropometric guidelines for adult hand sizes, supporting both thumb-index and palm-grip techniques.
Sample Compatibility & Compliance
The CRILE-WOOD Needle Holder is validated for use with all standard suture needle types—including reverse-cutting, taper, blunt, and spatula configurations—across diameters from 12 mm to 30 mm and gauges ranging from 6-0 to 2. It meets essential requirements of ISO 7153-1:2021 (Surgical Instruments — Metallic Materials — Part 1: Stainless Steels) and conforms to the mechanical performance criteria outlined in ISO 80369-3 for small-bore connectors used in surgical instrumentation accessories. While not intended for implantation, its surface finish (Ra ≤ 0.4 µm after electropolishing) satisfies cleaning validation thresholds per ISO 15883-1 for reusable medical devices. Device labeling complies with UDI requirements under MDR (EU 2017/745) Annex I, Section 23.2.
Software & Data Management
As a Class I non-powered, non-measuring manual surgical instrument, the CRILE-WOOD Needle Holder does not incorporate embedded electronics, firmware, or software components. Consequently, it requires no cybersecurity protocols, data logging, or electronic record integration. Instrument traceability is maintained through laser-engraved alphanumeric identifiers (model number, batch code, CE mark, and manufacturer logo) on the handle shank—supporting inventory management, recall readiness, and GLP-compliant documentation in clinical and preclinical research settings.
Applications
- Primary wound closure in general and trauma surgery, particularly where high-tensile-strength sutures (e.g., polypropylene, polyester, or stainless steel wire) are employed.
- Fine-tissue approximation in oculoplastic and microvascular procedures requiring minimal needle deflection and consistent rotational control.
- Veterinary soft-tissue repair, including abdominal coeliotomy and orthopedic ligament reconstruction, where instrument durability under repetitive stress is critical.
- Preclinical surgical training modules accredited by AALAS and FELASA, serving as a benchmark tool for evaluating suturing proficiency and hand–eye coordination metrics.
- Regulatory-compliant device evaluation studies where standardized, non-variable instrumentation is required to isolate variables in suture performance testing (e.g., knot security, tissue pull-through force).
FAQ
What sterilization methods are validated for this needle holder?
Autoclaving at 134 °C for 18 minutes (prevacuum cycle) is fully validated; ethylene oxide (EtO) and low-temperature hydrogen peroxide plasma sterilization are also compatible.
Is the instrument suitable for use with coated or specialty needles?
Yes—its micro-serrated jaws provide reliable grip on silicone-, PTFE-, and polybutester-coated needles without compromising coating integrity.
Does RWD offer customization options such as tungsten carbide inserts or custom length variants?
Custom configurations—including TC jaw inserts, matte-finish handles, or bespoke lengths—are available under OEM/ODM agreements with minimum order quantities.
How is batch traceability ensured for quality audits?
Each unit bears permanent laser marking including model code, production batch ID, and manufacturing date—fully aligned with ISO 13485:2016 clause 7.5.9 on identification and traceability.
Can this instrument be used in MRI environments?
Yes—constructed from non-magnetic austenitic stainless steel, it poses no risk of projectile effect or image distortion under 3T MRI field conditions.
