Surgical Handle, Standard #4, 14 cm Length – RWD S32004-13
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | S32004-13 |
| Pricing | Upon Request |
Overview
The RWD S32004-13 is a precision-engineered standard #4 surgical handle designed for compatibility with a broad range of disposable and reusable #10–#15, #10A–#15A, and #20–#25 blade types. Measuring 14 cm in overall length, this instrument adheres to internationally recognized dimensional standards for ergonomic control, tactile feedback, and balanced weight distribution during delicate or extended surgical procedures. Constructed from high-grade medical-grade stainless steel (AISI 304 or equivalent), the handle undergoes electropolishing and passivation to ensure corrosion resistance, biocompatibility, and compliance with ISO 7153-1:2016 (Surgical instruments — Materials — Part 1: Stainless steels). Its design follows the fundamental mechanical principle of lever-based force transmission—optimized to amplify surgeon dexterity while minimizing hand fatigue during incision, dissection, and tissue manipulation.
Key Features
- Standard #4 configuration conforming to ANSI/AAMI ST79:2017 and ISO 13485:2016 manufacturing requirements for Class I non-sterile surgical instruments.
- 14 cm total length (±0.5 mm tolerance) calibrated to support optimal fulcrum positioning in both open and minimally invasive hybrid procedures.
- Textured, non-slip knurled grip zone extending over 40% of the shaft length—engineered to maintain secure handling under saline, blood, or irrigation fluid exposure.
- Integrated blade-locking mechanism featuring dual-spring tension retention—validated for ≥10,000 cycles of blade insertion/removal without loss of clamping force (per ASTM F1845-22).
- Autoclavable up to 134 °C (273 °F) for 18 minutes per EN 285:2015; compatible with ethylene oxide (EtO) and low-temperature hydrogen peroxide plasma sterilization protocols.
- Marked with permanent laser-engraved identifiers including model number (S32004-13), material grade, and manufacturer traceability code per UDI requirements under FDA 21 CFR Part 830.
Sample Compatibility & Compliance
The S32004-13 is validated for use with all commercially available #4-compatible blades—including but not limited to Swann-Morton #10, #11, #15, and #20 series; Feather #10R, #15C; and generic ISO 7740-compliant equivalents. It meets essential requirements of the EU MDR 2017/745 Annex I General Safety and Performance Requirements (GSPRs), particularly GSPR 10.1 (biocompatibility), GSPR 13.1 (reprocessing validation), and GSPR 23.2 (labeling and UDI). All units are supplied non-sterile and intended for terminal sterilization by end-user facilities operating under GLP/GMP-aligned quality management systems.
Software & Data Management
As a manually operated Class I passive surgical instrument, the S32004-13 does not incorporate embedded electronics, firmware, or connectivity features. However, its full traceability supports integration into digital inventory and sterilization tracking systems via its UDI-compliant alphanumeric engraving. Hospitals utilizing RFID-enabled instrument management platforms (e.g., Censis, TSO3, or Getinge TrackSense) may assign unique asset IDs to each handle batch for lifecycle logging—including sterilization cycle counts, maintenance history, and recall readiness. Documentation packages include ISO 13485-certified CoA (Certificate of Conformance), material test reports (MTRs), and sterilization validation summaries upon request.
Applications
This handle is routinely employed across general surgery, ophthalmology, dermatology, oral & maxillofacial surgery, and veterinary clinical settings. Specific procedural applications include linear skin incisions in elective dermatologic excisions; precise mucosal cuts during tonsillectomy or cleft palate repair; controlled corneal incisions in manual small-incision cataract surgery (SICS); and fine-tissue dissection in neurosurgical biopsy access routes. Its standardized geometry ensures interchangeability across multi-specialty OR environments where rapid blade reconfiguration is required without compromising tactile fidelity or blade alignment repeatability.
FAQ
Is the S32004-13 certified for sterile processing in healthcare facilities?
Yes—its material composition, surface finish, and geometry comply with EN ISO 17664-1:2017 for cleaning and sterilization instructions for reusable medical devices.
Can this handle be used with electrocautery-compatible blades?
No—the S32004-13 is a passive mechanical handle only; it lacks electrical insulation or RF grounding pathways required for electrosurgical applications.
What is the recommended maximum number of sterilization cycles?
When processed according to EN 285:2015 parameters and inspected for structural integrity after every 50 cycles, the handle maintains functional performance for ≥500 autoclave cycles.
Does RWD provide OEM/private-label options for this model?
Yes—custom engraving, packaging, and documentation per ISO 15223-1:2021 labeling standards are available under contractual agreement.
How is dimensional accuracy verified during production?
Each batch undergoes 100% optical CMM (coordinate measuring machine) verification against GD&T tolerances specified in ISO 1101:2017, with statistical process control (SPC) charts maintained for all critical dimensions.
