RWD F33001-01 Round Body Suture Needle (10 pcs/box)

Overview

The RWD F33001-01 Round Body Suture Needle is a precision-engineered surgical needle designed for soft tissue approximation in preclinical research and laboratory-based biomedical procedures. Unlike cutting or reverse-cutting needles, the round-bodied design features a smooth, non-cutting cross-section that minimizes tissue trauma during passage—making it especially suitable for delicate structures such as blood vessels, nerves, gastrointestinal mucosa, and embryonic or neonatal tissues. Constructed from high-grade stainless steel (typically AISI 304 or equivalent biocompatible alloy), the needle undergoes stringent metallurgical control, electropolishing, and passivation to ensure consistent sharpness, corrosion resistance, and dimensional repeatability. Its geometry adheres to internationally recognized suture needle standards (e.g., ISO 7888:2019 — “Sutures — Needles”), supporting reproducible handling and predictable tissue penetration behavior across experimental replicates.

Key Features

• Round-body profile with uniform circular cross-section for low-resistance tissue traversal and reduced mechanical damage
• Precision-ground, self-sharpening point geometry optimized for controlled penetration depth and minimal deflection
• Electropolished surface finish achieving Ra ≤ 0.2 µm, minimizing protein adhesion and facilitating sterilization efficacy
• Consistent needle curvature (standard 3/8 circle arc) calibrated to match standard needle holder jaw dimensions (e.g., Castroviejo or Mikulicz-type holders)
• Individually packaged in sterile, peel-open blister cards compliant with ISO 11607-1 for primary packaging integrity
• Batch traceability supported via laser-etched lot number and expiration date on secondary packaging

Sample Compatibility & Compliance

The F33001-01 is validated for use with monofilament and braided absorbable and non-absorbable suture materials (e.g., polypropylene, nylon, polyglycolic acid, and silk) ranging from USP 6-0 to 4-0 diameters. It is routinely employed in rodent, rabbit, and porcine models for vascular anastomosis, intestinal resection, corneal suturing, and neural repair studies. All production conforms to ISO 13485:2016 quality management system requirements for medical device manufacturers. The product meets ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation) biocompatibility testing protocols. Sterilization is performed via ethylene oxide (EtO) gas under validated cycles per ISO 11135, with residual EtO levels verified below 4.0 µg/g per ISO 10993-7.

Software & Data Management

As a passive surgical instrument, the F33001-01 does not incorporate embedded electronics or digital interfaces. However, its integration into regulated research environments is supported through comprehensive documentation packages—including Device Master Record (DMR), Certificate of Conformance (CoC), and sterilization validation reports—available upon request for GLP- or GCP-compliant study submissions. Lot-specific test data (e.g., tensile strength, bending stiffness, and penetration force per ASTM F2118-20 Annex A1) can be provided to support protocol development and audit readiness. Traceability records align with FDA 21 CFR Part 11 principles for electronic record retention where applicable in hybrid lab workflows.

Applications

• Microvascular anastomosis in murine hindlimb ischemia or cerebral reperfusion models
• Intestinal anastomosis following partial colectomy in rat IBD studies
• Corneal epithelial wound closure in ocular toxicity or regeneration assays
• Suturing of dural membranes during stereotactic intracranial injection procedures
• Embryonic tissue grafting in ex ovo chick chorioallantoic membrane (CAM) assays
• Training modules for veterinary and biomedical graduate students in aseptic technique and fine-motor skill development

FAQ

Is the F33001-01 compatible with automated suture devices or robotic surgical platforms?
No—it is a manually operated, hand-held suture needle intended for use with standard surgical needle holders; no electromechanical interface or proprietary driver mechanism is included.
What is the recommended storage condition for unopened packages?
Store at room temperature (15–25°C), protected from direct sunlight and ambient humidity; do not freeze or expose to repeated thermal cycling.
Can this needle be resterilized after initial use?
No—single-use only per ISO 15223-1 labeling requirements; reuse compromises structural integrity and sterility assurance.
Does RWD provide custom packaging or OEM labeling for institutional procurement?
Yes—custom packaging configurations (e.g., bulk packs, barcoded inventory units, or institution-branded labels) are available under NDA-supported OEM agreements.
Are Material Safety Data Sheets (MSDS) or ISO 10993 test reports available?
Yes—certified biocompatibility documentation and material composition statements are provided upon formal request with institutional affiliation verification.