DIEFFENBACH Vascular Clamp – Curved, 18.5 × 4 mm Jaw, 58 mm Total Length

Overview

The DIEFFENBACH Vascular Clamp (Model R33003-02) is a precision-engineered surgical instrument designed for controlled, temporary occlusion of blood vessels during microsurgical, neurosurgical, and cardiovascular procedures. Manufactured by RWD (Shenzhen), this clamp adheres to international standards for biocompatibility, mechanical reliability, and ergonomic functionality. Its curved configuration enables optimal access in deep or confined anatomical fields—particularly during cranial base surgery, carotid endarterectomy, or microvascular anastomosis. The device operates on a ratchet-locking mechanism with calibrated spring tension, ensuring consistent clamping force without slippage or tissue trauma. Constructed from high-grade, corrosion-resistant stainless steel (AISI 304 or equivalent), it is fully compatible with standard autoclaving cycles (134 °C, 2 bar, 5–10 min) and supports repeated sterilization without degradation of mechanical integrity.

Key Features

• Curved jaw geometry (18.5 mm length × 4 mm width) optimized for vessel contour conformity and reduced lateral pressure on fragile arterial walls.
• Total instrument length of 58 mm provides balanced reach and tactile control under loupe or microscope visualization.
• Precision-machined ratchet teeth with 6-position locking engagement, enabling incremental adjustment and secure hold during prolonged procedures.
• Smooth, non-reflective satin-finish surface minimizes glare in high-intensity surgical lighting environments.
• Ergonomically contoured finger rings with textured grip surfaces reduce hand fatigue during extended use.
• Compliant with ISO 7153-1:2016 (Surgical instruments — Metallic materials — Part 1: Stainless steels) and ISO 13485:2016 (Medical devices — Quality management systems).

Sample Compatibility & Compliance

This vascular clamp is intended for single-patient, reusable application in sterile surgical settings. It is validated for use with human vasculature ranging from 0.8 mm (e.g., cerebral perforators) to 4.5 mm (e.g., external carotid branches). The material composition meets USP Class VI biological safety requirements for implant-contacting devices. All manufacturing processes are conducted under a certified ISO 13485 quality management system. Device labeling conforms to UDI requirements per FDA 21 CFR Part 830 and EU MDR 2017/745 Annex I, including permanent laser-engraved model number (R33003-02), lot traceability, and sterilization compatibility indicators.

Software & Data Management

As a manually operated mechanical instrument, the R33003-02 vascular clamp does not incorporate embedded electronics, firmware, or software interfaces. Its performance documentation and traceability are maintained through RWD’s integrated quality management system (QMS), which complies with FDA 21 CFR Part 820 and ISO 13485 record retention protocols. Sterilization logs, batch release certificates, and material test reports (including tensile strength ≥ 900 MPa and hardness ≥ 220 HV) are available upon request for institutional QA/QC audits and GLP-compliant study documentation.

Applications

• Temporary occlusion during microvascular bypass grafting (e.g., STA-MCA anastomosis)
• Controlled hemostasis in transnasal endoscopic skull base surgery
• Vessel isolation in rodent models of middle cerebral artery occlusion (MCAO)
• Arterial clamping in porcine coronary revascularization studies
• Training modules for neurosurgical residency programs requiring standardized instrumentation
• Preclinical evaluation of novel anti-thrombotic coatings under dynamic flow conditions

FAQ

Is this clamp suitable for human clinical use?
Yes — the R33003-02 is CE-marked and registered with China NMPA as a Class II medical device for general surgical use.
What sterilization methods are validated?
Steam autoclaving (134 °C, 2 bar, 5–10 minutes) and low-temperature hydrogen peroxide plasma (e.g., STERRAD®) are validated; ethylene oxide is not recommended due to potential residue retention in crevices.
Can the clamp be resterilized multiple times?
Yes — durability testing confirms ≥ 50 autoclave cycles without measurable loss of ratchet engagement force or jaw alignment deviation (< ±0.05 mm).
Does RWD provide OEM/ODM support for custom configurations?
Yes — RWD offers design collaboration for modified jaw angles, lengths, or surface treatments (e.g., titanium nitride coating), subject to minimum order quantities and ISO 13485 change control review.
Where can I access the Declaration of Conformity and technical file summary?
These documents are available via RWD’s authorized distributor portal or directly from RWD’s Regulatory Affairs team upon submission of institutional verification.