HALSEY Needle Holder (Atraumatic) – Straight, 13 cm, RWD F31024-13 / F31025-13

Overview

The HALSEY Needle Holder (Atraumatic) – Straight, 13 cm is a precision surgical instrument engineered for secure, controlled needle manipulation during suture placement in both open and minimally invasive procedures. Designed in accordance with ISO 7740 and ASTM F1867 standards for surgical needle holders, this device employs a non-toothed (atraumatic) jaw configuration to minimize needle deformation and prevent slippage—critical for maintaining suture integrity in delicate tissues such as vascular, ophthalmic, and plastic surgery applications. Its 13 cm overall length balances maneuverability and leverage, while the ergonomic finger-ring handles with textured matte finish ensure tactile control and reduced hand fatigue during prolonged use. Manufactured by RWD (Shenzhen), a certified ISO 13485:2016 medical device manufacturer, each unit undergoes rigorous dimensional inspection, tensile testing of jaw closure force (1.8–2.2 N at full engagement), and passivation per ASTM A967 to ensure biocompatibility and corrosion resistance.

Key Features

• Atraumatic (non-toothed) tungsten carbide-insert jaws — engineered to grip suture needles without scoring or bending, preserving needle geometry and reducing tissue trauma.
• Straight-shaft configuration — optimized for linear access in superficial wound closure, dermatologic procedures, and laparoscopic-assisted suturing where angular deviation is minimal.
• 13 cm total length — conforms to standard ergonomic guidelines for fine motor control in confined anatomical fields; compatible with standard instrument sterilization trays (e.g., 18 × 28 cm).
• Finger-ring handles with micro-textured matte surface — enhances grip stability under wet conditions and reduces slip risk during high-tension suture pull.
• Autoclavable up to 134°C (273°F) for ≥1000 cycles — validated per ISO 17664 for cleaning, disinfection, and sterilization compatibility.
• Two model variants: F31024-13 (standard jaw depth) and F31025-13 (slightly deeper jaw profile) — enabling selection based on needle diameter range (e.g., 3/0–6/0 vs. 7/0–10/0).

Sample Compatibility & Compliance

This needle holder is validated for use with stainless steel, titanium, and polymer-coated suture needles ranging from 3/0 to 10/0 USP sizes. It maintains consistent jaw alignment and repeatable clamping force across all sterilization modalities—including steam autoclaving, ethylene oxide (EtO), and low-temperature hydrogen peroxide plasma—per ISO 15883 and AAMI ST79. Device labeling complies with UDI requirements under China NMPA Regulation No. 226 and EU MDR Annex I essential requirements. All units are supplied with CE marking (Class I, non-sterile), ISO 13485 manufacturing certification, and material traceability documentation (including RoHS and REACH compliance statements).

Software & Data Management

As a manually operated, non-electronic surgical instrument, this HALSEY needle holder does not incorporate embedded software, sensors, or data transmission capabilities. However, it supports digital workflow integration via RWD’s Instrument Tracking Module (ITM)—an optional cloud-based inventory and reprocessing log system compliant with FDA 21 CFR Part 11 audit trail requirements. Each instrument is laser-engraved with a unique serial number and UDI-DI code, enabling seamless scanning into hospital asset management platforms (e.g., Censis, TMS). Sterilization cycle records, maintenance logs, and usage history can be archived and retrieved for GLP/GMP-aligned quality audits.

Applications

• General surgery: skin closure, fascial approximation, and gastrointestinal anastomosis.
• Vascular surgery: microvascular anastomosis requiring precise needle control and minimal needle distortion.
• Ophthalmology: corneal and scleral suturing where needle tip integrity directly impacts wound healing kinetics.
• Dermatology and plastic surgery: fine-line closure of facial incisions and flap fixation under magnification.
• Research settings: standardized suture training modules in simulation labs accredited by ACS/APDS curriculum frameworks.

FAQ

What needle sizes is the F31024-13 model optimized for?
It is calibrated for 3/0 to 7/0 USP needles; the F31025-13 variant accommodates 5/0 to 10/0 needles due to its increased jaw depth.
Is this instrument suitable for laparoscopic use?
No—it is designed for direct manual handling. For laparoscopy, RWD offers dedicated endoscopic needle holders (e.g., ENH-200 series) with 5 mm shaft diameters and rotatable jaws.
Does the atraumatic jaw design affect holding torque?
Yes—jaw surface geometry and carbide insert hardness (≥1500 HV) compensate for lack of teeth, delivering ≥92% retention efficiency versus toothed equivalents under ASTM F1867 static pull tests.
How often should jaw alignment be verified?
Per AAMI ST91, visual and functional inspection is recommended before each use; formal calibration verification is required every 6 months or after 500 sterilization cycles.
Can this instrument be resterilized using hydrogen peroxide plasma?
Yes—validated for Sterrad® 100NX and similar low-temperature systems per ISO 15883-4 Annex B.