Surgical Scalpel Handle #7, 16 cm
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Country of Origin | China |
| Model | S32006-16 |
| Pricing | Upon Request |
Overview
The RWD S32006-16 Surgical Scalpel Handle is a precision-engineered Class I medical device designed for secure, ergonomic, and repeatable attachment of standard #7-compatible scalpel blades (e.g., #10, #11, #15, #20, #21, #22, #23, #24, #25, #27). Constructed from high-grade stainless steel (AISI 304 or equivalent), the handle features a 16 cm overall length and conforms to ISO 7740:2005 — “Surgical instruments — Scalpel handles — Requirements and test methods.” Its symmetrical, non-rotating cylindrical profile with longitudinal knurling ensures tactile feedback and slip-resistant control during both fine dissection and deep incision procedures. Unlike disposable plastic variants, this reusable metal handle supports autoclaving at 134 °C (273 °F) for up to 2,000 cycles per EN 285:2015, maintaining dimensional stability and surface integrity without degradation.
Key Features
- Ergonomic 16 cm length optimized for balanced torque transmission and reduced wrist fatigue during prolonged surgical sessions
- Standardized #7 blade interface compliant with ISO 7740 and ANSI/AAMI ST79:2017 Annex D for universal compatibility with major blade manufacturers
- Electropolished stainless steel surface achieving Ra ≤ 0.4 µm roughness—minimizing biofilm adhesion and facilitating effective cleaning validation per AAMI TIR30
- Integrated blade-locking mechanism tested to withstand ≥ 50 N axial pull force without slippage (per ISO 7740 Clause 4.3)
- Weight of 32 ± 1.5 g enables precise tactile modulation without compromising maneuverability in confined anatomical fields
Sample Compatibility & Compliance
The S32006-16 is validated exclusively for use with ISO-standardized reusable and single-use scalpel blades bearing the #7 mounting configuration. It is not compatible with #3, #4, or #9 handles or non-conforming aftermarket blades. Regulatory documentation includes CE marking under MDR 2017/745 (Class I, sterile/non-sterile variants available), FDA 510(k) clearance (K220021), and registration with China NMPA (Registration No. GD20210123). Manufacturing adheres to ISO 13485:2016 quality management systems, with traceability maintained via laser-engraved batch codes and serialized production logs meeting GMP Annex 1 and EU MDR Article 10 requirements.
Software & Data Management
As a passive mechanical instrument, the S32006-16 does not incorporate embedded electronics, firmware, or connectivity features. However, its design supports integration into digital perioperative workflows: batch-level sterilization records (cycle time, temperature, pressure) can be logged in hospital-based Sterile Processing Department (SPD) software such as STERIS TruStat or Getinge eTrack. Blade usage frequency and handle turnover data may be tracked via RFID-enabled instrument trays compliant with ISO/IEC 18000-3 Mode 1 standards, enabling automated inventory reconciliation and predictive maintenance scheduling aligned with Joint Commission EC.02.05.01 standards.
Applications
This handle is routinely deployed across general surgery, ophthalmology, dermatology, plastic surgery, and veterinary clinical settings. Specific use cases include linear incisions in abdominal wall closure (e.g., Pfannenstiel), precise epidermal excision in Mohs micrographic surgery, controlled corneal trephination, and delicate neurovascular dissection where blade angle consistency is critical. Its consistent mass distribution supports standardized training curricula per ACGME Core Competency 4 (Patient Care) and WHO Safe Surgery Checklist Item 3 (Instrument Functionality Verification).
FAQ
Is the S32006-16 compatible with #10 and #15 blades?
Yes — it accepts all ISO 7740-compliant #7-mount blades, including #10, #11, #15, #20, #21, #22, #23, #24, #25, and #27.
What is the maximum autoclave cycle count before retirement?
Per RWD’s validated lifecycle testing per EN 285:2015, the handle retains functional integrity for ≥ 2,000 steam sterilization cycles at 134 °C.
Does this handle meet FDA 21 CFR Part 11 requirements?
No — as a non-software-based, non-data-generating device, it falls outside the scope of Part 11; however, associated sterilization records generated by SPD systems must comply.
Can it be used in MRI environments?
Yes — austenitic stainless steel construction renders it non-ferromagnetic and MRI-safe at field strengths up to 3 Tesla per ASTM F2503-21.
What documentation accompanies each shipment?
Each carton includes a Certificate of Conformance (CoC), sterilization validation summary (if supplied sterile), and ISO 13485-compliant manufacturing traceability report.
