Kelly RWD Precision Hemostat (Straight & Curved, 1.5 mm Jaw Width, 14 cm Length)
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model Numbers | F21007-14 (Straight), F21008-14 (Curved) |
| Pricing | Available Upon Request |
Overview
The Kelly RWD Precision Hemostat is a high-fidelity surgical instrument engineered for controlled vascular occlusion and delicate tissue manipulation in open and minimally invasive procedures. Designed in strict accordance with ISO 7153-1:2016 (Surgical Instruments — Metallic Materials — Part 1: Stainless Steel) and compliant with YY/T 0171–2020 (Chinese National Standard for Surgical Instruments — General Requirements), this hemostat leverages a precision-ground 1.5 mm jaw width and optimized ratchet geometry to deliver consistent clamping force without slippage or tissue trauma. Its 14 cm overall length provides ergonomic reach while maintaining fine motor control—critical for neurosurgical, ophthalmic, plastic, and microvascular applications where spatial constraints and tactile feedback are paramount. Constructed from medical-grade AISI 420 stainless steel, the instrument undergoes passivation per ASTM A967 and electropolishing to achieve Ra ≤ 0.4 µm surface roughness, minimizing protein adhesion and supporting validated cleaning and sterilization cycles (steam autoclaving at 134 °C, 3 min; ethylene oxide; hydrogen peroxide plasma).
Key Features
- Precision-machined 1.5 mm parallel jaw profile ensures uniform pressure distribution across vessel walls—reducing risk of intimal injury during temporary occlusion.
- Asymmetric ratchet mechanism with seven locking positions enables incremental force adjustment and secure hold under dynamic intraoperative conditions.
- Ergonomic finger-ring handles with matte satin finish provide slip-resistant grip and fatigue-reducing leverage during prolonged use.
- Both straight (Model F21007-14) and curved (Model F21008-14) configurations support anatomical access in confined fields—e.g., deep pelvic dissection or intracranial retraction.
- Full traceability via laser-engraved model number, batch ID, and CE/ISO 13485:2016 certification mark on the shank.
Sample Compatibility & Compliance
The Kelly RWD Precision Hemostat is intended for single-patient, reusable use in sterile environments. It is compatible with all standard sterilization modalities validated for Class IIa surgical instruments under EU MDR 2017/745 and FDA 21 CFR Part 820. Instrument compatibility has been verified with common surgical drapes, suction tubing, and endoscopic port systems (including 5 mm and 10 mm laparoscopic trocars). All materials comply with ISO 10993-1 (Biological Evaluation of Medical Devices) for cytotoxicity, sensitization, and irritation testing. The device carries CE marking under Annex II (Full Quality Assurance) and meets RoHS Directive 2011/65/EU requirements for restricted substances.
Software & Data Management
As a manually operated mechanical device, the Kelly RWD Precision Hemostat requires no embedded electronics, firmware, or software integration. However, its design supports digital workflow interoperability: model-specific data (F21007-14/F21008-14) is included in RWD’s ISO 13485-certified quality management system (QMS), enabling full audit trail generation for sterilization logs, maintenance records, and reprocessing validation reports. Institutions utilizing RFID-enabled instrument tracking systems (e.g., Terso, CensiTrak) may assign unique identifiers to each unit for lifecycle monitoring, recall readiness, and GLP/GMP-aligned inventory reconciliation.
Applications
- Temporary arterial/venous clamping during anastomosis in cardiovascular and transplant surgery.
- Controlled hemorrhage management in trauma and emergency laparotomy.
- Fine-tissue retraction and stabilization in facial plastic and reconstructive procedures.
- Microdissection support in otolaryngology and neurosurgery (e.g., acoustic neuroma resection).
- Adjunctive use in endoscopic-assisted transnasal skull base approaches requiring angled visualization.
FAQ
Is the Kelly RWD Precision Hemostat suitable for autoclaving?
Yes—validated for repeated steam sterilization at 134 °C for 3 minutes (EN 285), including full-cycle exposure with porous load parameters.
What is the recommended reprocessing protocol?
Follow AAMI ST79:2023 guidelines: ultrasonic cleaning (≥ 40 kHz, enzymatic detergent, 5–10 min), thorough rinsing, thermal disinfection (≥ 93 °C, 5 min), drying, and inspection prior to sterilization.
Does RWD provide instrument-specific IFU documentation in English?
Yes—each shipment includes bilingual (English/Chinese) Instructions for Use compliant with ISO 15223-1:2021 and annotated with UDI-DI elements per GS1 standards.
Can these hemostats be integrated into automated instrument tracking systems?
Yes—flat, unobstructed shank surface allows reliable laser engraving of 2D data matrix codes compatible with hospital-wide RFID and barcode scanning infrastructure.
What is the expected service life under proper reprocessing?
When maintained per manufacturer specifications—including ratchet lubrication every 50 sterilization cycles—the functional lifespan exceeds 500 uses with documented mechanical integrity.
