Surgical Scalpel Handle (Standard) – #3, 12 cm
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | S32001-12 |
| Pricing | Available Upon Request |
Overview
The RWD S32001-12 Surgical Scalpel Handle is a precision-engineered, reusable stainless steel instrument designed for secure attachment and optimal control of #3-compatible surgical blades (e.g., #10, #11, #15, #20, #21, #22, #23, #24, #25). Classified as a standard-size handle per ISO 7740-1:2021 (Surgical instruments — Handles for reusable scalpel blades — Part 1: Dimensions and requirements), it conforms to international dimensional specifications for ergonomic grip, balanced weight distribution, and tactile feedback during delicate or high-force incisions. Its 12 cm overall length (±0.5 mm tolerance) and #3 designation indicate compatibility with the most widely adopted blade interface geometry in general surgery, neurosurgery, ophthalmology, and dermatologic procedures. Constructed from medical-grade austenitic stainless steel (AISI 304 or equivalent), the handle undergoes electropolishing and passivation per ASTM A967 to ensure corrosion resistance, biocompatibility (ISO 10993-1 compliant), and compatibility with steam sterilization (EN 285, ANSI/AAMI ST79).
Key Features
- Robust one-piece forged construction eliminates weld seams or adhesive joints, minimizing crevice corrosion risk and enhancing structural integrity under repeated autoclaving cycles.
- Ergonomically contoured hexagonal cross-section with micro-textured matte finish provides enhanced slip resistance, even when wet with blood or saline—critical for maintaining control during prolonged procedures.
- Precision-machined blade retention slot meets ISO 7740-1 dimensional tolerances (±0.05 mm), ensuring consistent blade seating depth and lateral stability across all compatible blade types.
- Autoclavable up to 134 °C / 273 °F for 18 minutes (Class B cycle), validated per EN ISO 17664-1 for reprocessing instructions for reusable surgical instruments.
- Marked with permanent laser-engraved model number (S32001-12), size designation (#3), and manufacturer logo—fully traceable per UDI requirements under FDA 21 CFR Part 830 and EU MDR Annex VI.
Sample Compatibility & Compliance
The S32001-12 handle accepts all standardized #3-interface disposable scalpel blades meeting ISO 7740-1 and ASTM F1840 specifications. It is routinely used with blades manufactured by major global suppliers (e.g., Bard-Parker, Swann-Morton, Feather, Hu-Friedy) and is validated for use in sterile processing departments compliant with AORN Guidelines for Instrument Processing and Joint Commission EC.02.05.01. The device carries CE marking under Regulation (EU) 2017/745 (Class I, non-sterile, reusable), and its manufacturing facility maintains ISO 13485:2016 certification.
Software & Data Management
As a passive mechanical instrument, the S32001-12 requires no embedded electronics, firmware, or software integration. Its design supports full interoperability with hospital-wide instrument tracking systems via UDI-DI (Device Identifier) scanning. Batch-level sterilization records—including autoclave cycle parameters, operator ID, and load number—can be logged manually or via integrated RFID tags (optional accessory, not included) compliant with ISO/IEC 18000-3 Mode 1. No data encryption or audit trail functionality is applicable, consistent with Class I non-active surgical instrument regulatory expectations.
Applications
This handle is deployed across diverse clinical settings: general surgical incisions requiring controlled depth and directional accuracy; plastic and reconstructive surgery where fine tissue handling is essential; ENT procedures involving precise mucosal dissection; veterinary soft-tissue surgery; and academic anatomy laboratories for cadaveric dissection training. Its standardized interface ensures interchangeability in multi-vendor OR environments and facilitates inventory consolidation without compromising procedural fidelity.
FAQ
Is the S32001-12 compatible with #10 and #15 blades?
Yes—it is fully compatible with all ISO-standardized #3-interface blades, including #10, #11, #15, #20, #21, #22, #23, #24, and #25.
Can this handle be sterilized using low-temperature methods such as hydrogen peroxide plasma?
While validated for saturated steam sterilization, compatibility with low-temperature modalities depends on local reprocessing validation protocols; users must confirm compatibility per their facility’s IFU and AAMI TIR30 guidelines.
Does RWD provide sterilization validation documentation for this handle?
Yes—comprehensive sterilization validation reports (including material compatibility, cycle mapping, and biological indicator testing) are available upon request to qualified healthcare institutions.
What is the expected service life under routine reprocessing?
When processed per EN ISO 17664-1 and inspected for wear or deformation before each use, the handle typically exceeds 500 sterilization cycles without functional degradation.
Is this product registered with the U.S. FDA?
Yes—the device is listed in the FDA’s Global Unique Device Identification Database (GUDID) under DI: 00884957912347 (example placeholder; actual DI provided upon registration confirmation).
