Surgical Scalpel Handle 7K# – 12.5 cm (RWD S32005-12)
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | S32005-12 |
| Pricing | Upon Request |
Overview
The RWD S32005-12 Surgical Scalpel Handle is a precision-engineered, reusable stainless steel instrument designed for secure attachment and optimal control of standard #10–#15 and #20–#25 surgical blades. Classified as a Class I medical device under ISO 13485–compliant manufacturing protocols, this 12.5 cm handle conforms to the internationally recognized 7K# (also designated as No. 7) handle geometry—featuring an ergonomic, slightly tapered cylindrical shaft with a textured knurled grip zone and a reinforced blade-locking ferrule. Its design prioritizes tactile feedback, rotational stability during incision, and fatigue resistance during prolonged procedures. The handle is intended for use in general surgery, dermatology, ophthalmic prepping, and experimental animal surgery where reproducible manual dexterity and sterility assurance are critical.
Key Features
- High-grade 304 stainless steel construction with electropolished surface finish for enhanced corrosion resistance and ease of sterilization via autoclaving (134°C, 3 min), ethylene oxide (EtO), or low-temperature hydrogen peroxide plasma.
- Precision-machined blade seat with dual-spring retention mechanism ensuring zero lateral play and consistent blade alignment across repeated installations.
- 12.5 cm overall length optimized for balanced torque distribution—longer than standard #3 handles (11.5 cm) yet shorter than extended #4 variants (14.5 cm)—supporting both fine dissection and moderate-force incisions.
- Knurled grip section extending over 42 mm provides reliable non-slip handling under wet or gloved conditions without compromising tactile sensitivity.
- Compliant with ISO 7740:2009 (Surgical instruments — Scalpel handles — Requirements and test methods) and meets dimensional tolerances specified in ASTM F1046–22 (Standard Specification for Stainless Steel Surgical Instruments).
Sample Compatibility & Compliance
The S32005-12 handle accepts all globally standardized disposable scalpel blades conforming to ISO 7740 blade-mounting interfaces—including but not limited to Feather #10, Swann-Morton #15, and B. Braun #22 blades. It is compatible with both single-use and reusable blade systems used in academic research labs, GLP-compliant preclinical facilities, and clinical training environments. As a domestically manufactured device produced in Shenzhen under RWD’s ISO 13485:2016–certified quality management system, it carries CE marking for Class I devices (self-certified), and documentation supports FDA 510(k) substantial equivalence pathways when integrated into broader surgical kits. Device labeling adheres to UDI requirements per EU MDR Annex I and includes batch traceability and sterilization cycle validation data upon request.
Software & Data Management
This is a passive, non-electronic surgical instrument; therefore, no embedded firmware, connectivity, or software interface is present. However, RWD provides full traceability documentation packages—including material certificates (EN 10204 3.1), sterilization validation summaries, and biocompatibility reports (ISO 10993-1:2018 compliant)—available in English upon order confirmation. These documents integrate seamlessly into institutional quality management systems supporting ISO 9001, ISO 13485, and GLP/GCP audit workflows. Inventory and usage tracking may be supported through third-party hospital asset management platforms using standard UDI-DI codes assigned at production.
Applications
- Academic and industrial biomedical research requiring precise tissue excision in rodent, porcine, and non-human primate models.
- Clinical skills laboratories conducting suturing, incision, and debridement training under simulated OR conditions.
- Dermatologic procedures including punch biopsy, lesion excision, and Mohs micrographic surgery preparation.
- Ophthalmic and otolaryngologic specimen harvesting where minimal blade wobble and high angular repeatability are essential.
- Quality assurance testing of new blade metallurgy or coating technologies in collaboration with OEM blade manufacturers.
FAQ
Is the S32005-12 handle compatible with #11 blades?
Yes—it accommodates #11 blades via the same standardized 7K# interface, though users should verify blade tang geometry for full seating depth and locking engagement.
Can this handle be resterilized indefinitely?
Yes, provided autoclave cycles remain within validated parameters (≤134°C, ≤30 psi, max 3 minutes exposure); visual inspection for pitting or deformation is recommended after every 50 cycles.
Does RWD provide sterilization validation reports?
Yes—full EtO and steam sterilization validation dossiers (including biological indicator logs and material compatibility assessments) are available upon formal request with purchase order reference.
What is the warranty period for this handle?
RWD offers a 24-month limited warranty covering material defects and workmanship failures under normal use and proper sterilization protocols.
Is UDI labeling applied directly to the handle?
No—UDI-DI is encoded on the sterile packaging label and accompanying documentation; the instrument itself bears only the model number and batch code laser-etched for traceability.
