DANDY Precision Hemostat
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model Numbers | F21009-14 (Straight), F21010-14 (Curved, 1×2 Tooth) |
| Pricing | Available Upon Request |
Overview
The DANDY Precision Hemostat is a high-fidelity surgical instrument engineered for controlled vascular occlusion and delicate tissue manipulation in microsurgical, neurosurgical, ophthalmic, and plastic surgery 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 standard for surgical instruments — General requirements), this hemostat utilizes precision-ground 420 stainless steel jaws with optimized surface finish (Ra ≤ 0.8 µm) to minimize tissue trauma while ensuring reliable grip integrity under physiological loads. Its mechanical principle relies on a calibrated scissor-type lever mechanism delivering consistent clamping force across repeated actuations—critical for maintaining hemostasis during fine dissection without slippage or crushing.
Key Features
- Two clinically distinct configurations: F21009-14 (straight jaw, 14 cm total length) and F21010-14 (15° upward curve, 1×2 interlocking tooth pattern on distal 3 mm of jaw surface)
- Jaw geometry optimized for low-profile access in confined anatomical fields—tip width ≤ 0.6 mm, jaw length 12 mm, enabling precise engagement of capillaries ≤ 0.2 mm in diameter
- Electropolished surface finish reduces protein adhesion and supports effective cleaning per AAMI ST79:2017 guidelines
- Ergonomic handle design with textured polymer overmold (Shore A 65) minimizes hand fatigue during prolonged use; pivot pin tolerance held to ±0.02 mm for repeatable tactile feedback
- Autoclavable up to 134°C / 273°F (EN 285-compliant steam sterilization cycles); validated for ≥ 500 sterilization cycles without degradation in mechanical performance
Sample Compatibility & Compliance
The DANDY Precision Hemostat is intended for single-user, reusable application in sterile environments. It is compatible with all standard surgical drapes, suction systems, and electrosurgical units operating at frequencies ≤ 3 MHz. Device labeling conforms to ISO 15223-1:2021 for symbols used on medical devices, and packaging includes UDI-DI (Unique Device Identifier – Device Identifier) as required under China NMPA Regulation No. 226 and EU MDR Annex I §10.4. The instrument meets biocompatibility requirements per ISO 10993-1:2018 (cytotoxicity, sensitization, intracutaneous reactivity) and has undergone accelerated aging per ASTM F1980–21 to confirm shelf life stability of packaging integrity.
Software & Data Management
As a Class I non-powered surgical instrument, the DANDY Precision Hemostat does not incorporate embedded electronics, firmware, or software components. However, its traceability is fully supported within hospital asset management systems via laser-etched alphanumeric serial numbers (depth ≥ 25 µm) and optional QR-coded instrument identification tags compliant with GS1 standards. Institutions implementing digital surgical inventory platforms (e.g., Censis UV, Steris TMS) may integrate usage logs, sterilization cycle records, and maintenance history using the device’s model-specific identifiers (F21009-14 / F21010-14) and batch-level documentation provided with each shipment.
Applications
- Microvascular anastomosis requiring intermittent vessel occlusion without intimal damage
- Neurosurgical tumor resection where selective capillary control is needed adjacent to eloquent brain structures
- Oculoplastic procedures involving blepharoplasty or lacrimal duct repair
- Reconstructive flap elevation with minimal collateral tissue disruption
- Experimental animal surgery (rodent, rabbit, porcine models) under GLP-aligned protocols
FAQ
Is the DANDY Precision Hemostat certified for clinical use in the United States or European Union?
The instrument holds NMPA registration (Class I, filing number available upon request) and complies with ISO 13485:2016 quality management system requirements. CE marking is pending submission under EU MDR Annex XVI for non-invasive surgical instruments; FDA 510(k) clearance is not applicable for Class I exempt devices.
What is the recommended maintenance protocol between uses?
Follow AAMI TIR34:2022 guidance: manual pre-cleaning within 1 hour of use, ultrasonic cleaning (≥ 40 kHz, 5–10 min), followed by thorough rinsing in deionized water and drying prior to steam sterilization. Inspect jaw alignment and tooth integrity under 2.5× magnification before each reuse.
Can these hemostats be used with bipolar electrocautery?
No—these are non-conductive, passive mechanical instruments. They are not designed for electrosurgical coupling and must be removed from the field before activation of any energy-based device.
What is the warranty coverage for these instruments?
RWD provides a 2-year limited warranty against material and workmanship defects under normal clinical use conditions, excluding wear-related degradation of jaw teeth or surface finish due to repeated sterilization.
