RETRACTOR 245MM X 40MM MALLEABLE 41,0CM

RETRACTOR • 245MM X 40MM FLEXIBLE • 41.0CM • CE-CLASS I • ISO 13485:2016

Professional Flex Retractor with Extra-Wide, Adaptable Contact Surface for Gentle Tissue Management in Plastic-Reconstructive, Visceral and Orthopedic Surgery

The RETRACTOR 245 mm x 40 mm / 41.0 cm is a Class I medical device manufactured according to ISO 13485:2016. This highly flexible wide-blade retractor is specifically designed for maximal, individually shapable, and broad tissue retraction. With its exceptional 40 mm width, it provides an even larger, pressure-distributing contact zone and is ideal for the gentle exposure of extensive surgical sites with complex topography.

Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Extra-wide, malleable blade (245 mm x 40 mm) for maximum contact area and individual shaping
✔ Ideal working length of 41.0 cm for deep and wide surgical approaches
✔ High-quality, spring-elastic special steel – offers perfect compromise between flexibility and shape retention
✔ Fully rounded, high-polished blade edges for atraumatic tissue application
✔ Ergonomic angled T-handle for comfortable two-handed guidance and precise force control
✔ Matte, anti-reflective surface finish
✔ Excellent long-term stability of bending properties even after repeated sterilization
✔ Sterilizable and reusable

Benefits of the Extra-Wide Malleable Retractor:

• Maximum Contact Area & Pressure Distribution: The 40 mm wide blade significantly reduces pressure per unit area, protecting delicate tissue from necrosis or crushing.
• Adaptation to Complex Anatomy: The blade can be precisely shaped to fit curvatures like the thoracic aperture, iliac crest, or large joints for a perfect fit.
• Optimal Circumferential Exposure: Excellent for retracting entire wound margins in large defects, deep abscess cavities, or extensive tumor resections.
• Reduces Instrument Changes: Due to its size and flexibility, it can often replace multiple rigid retractors, speeding up workflow.
• Indispensable in Reconstructive Surgery: Particularly valuable in flap procedures, mesh implantations, and the dissection of large skin-soft tissue flaps.

Technical Specifications:

• Type: Extra-Wide Flexible Retractor / Malleable Wide Blade Retractor
• Blade Dimensions: 245 mm (Length) x 40 mm (Width)
• Overall Length: 41.0 cm
• Blade Property: Manually and reversibly bendable, spring-back
• Material: High-quality spring-hardened surgical stainless steel (e.g., 1.4310)
• Surface Finish: Matte (satin finish)
• Handle: Angled T-handle for optimal leverage and control
• Sterilization: Autoclavable up to 138°C (Steam Sterilization)
• Packaging: Individually packed in sterilizable plastic wrap with forming rail to prevent unwanted bending
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Areas of Application:

• Plastic and Reconstructive Surgery (e.g., DIEP flap, Latissimus flap, large defect coverage)
• Extensive Visceral Surgery (e.g., cystectomies, liver resections, rectal excisions)
• Orthopedic Surgery (e.g., revision arthroplasty, limb tumor surgery)
• Thoracic Surgery (e.g., thoracotomies)
• Dermatological major excisions
• Any procedure requiring large-area, tissue-sparing, and anatomically adapted retraction

Important Safety and Handling Information:

• FOR USE BY EXPERIENCED SURGEONS AND OPERATING ROOM PERSONNEL ONLY.
• Bending Process: Bend the blade only by hand using slow, controlled movements. Bending over a sharp edge (e.g., table edge) or using tools is strictly prohibited.
• Check for Material Fatigue: Before each use, inspect the blade for signs of material fatigue (fine cracks, permanent bend), especially at the junction to the handle. Replace if signs are present.
• Proper Reprocessing: Soak the instrument immediately after use and clean gently in a mesh tray. Try to straighten bends before sterilization.
• Storage: Always store flat and straight or in very wide curves to avoid permanent deformation.
• The wide, flexible construction requires sufficient space in the sterilization container.