DE BAKEY VASCULAR DILATATOR MALLEABLE 1,5MM 35,0CM

DE BAKEY VESSEL DILATOR FLEXIBLE 1.5MM • 35.0 CM • CE CLASS I • ISO 13485:2016

Ultra Long Standard Vessel Dilator for Extreme Deep Microvascular Surgery

The DE BAKEY VESSEL DILATOR FLEXIBLE 1.5MM 35.0 cm is a medical device of CE Class I according to ISO 13485:2016. This flexible standard dilator with extreme length was specifically developed for the gentle dilation of small to medium vessels in extreme deep microvascular surgery, plastic surgery and reconstructive vascular surgery procedures.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE Marking Class I (Regulation (EU) 2017/745 MDR)
✔ DeBakey Vessel Dilator with 1.5 mm diameter
✔ Flexible version for extreme deep standardized vessel dilation
✔ High-quality Stainless Steel 1.4301 – rust-free and biocompatible
✔ Tested Biocompatibility according to ISO 10993
✔ Standard 1.5 mm tip for small to medium vessels
✔ Extreme 35.0 cm length for extreme deep microvascular procedures
✔ Sterilizable and reusable
✔ Ultra long instrument for extreme deep standard vascular reconstructions

Benefits of the DeBakey Vessel Dilator:

• Ultra Long Flexibility: Bendable construction for gentle vessel dilation in extreme deep regions
• Standard Size with Maximum Reach: 1.5 mm ideal for small to medium vessels and extreme deep standard anastomoses
• Atraumatic Ultra Long Tip: Smooth polished surface minimizes vessel injuries
• Extreme Deep Handling: 35.0 cm length for excellent control in extreme deep regions
• Robust Ultra Long Design: Reliable instrument for extreme deep use

Technical Specifications:

• Model: DE BAKEY VESSEL DILATOR FLEXIBLE
• Total Length: 35.0 cm
• Diameter: 1.5 mm
• Construction: Flexible standard vessel dilator with extreme reach
• Tip: Rounded, atraumatic
• Material: Stainless Steel 1.4301
• Form: Straight, flexible ultra long shaft
• Surface: High-gloss polished for optimal gliding properties
• Flexibility: High for controlled adaptation in extreme depths
• Risk Class: I according to Regulation (EU) 2017/745 MDR

Fields of Application:

• Extreme deep microvascular anastomoses
• Plastic surgical extreme deep reconstructions
• Reconstructive vascular surgery in extreme deep regions
• Hand surgical extreme deep vascular reconstructions
• Extreme deep digital replantations
• Extreme deep free flap transplantations
• Peripheral extreme deep vessel procedures

Important Safety Information:

• FOR USE BY HIGHLY SPECIALIZED VASCULAR SURGICAL PROFESSIONALS ONLY
• Apply only under strict aseptic conditions in specialized centers
• Check for damage and surface integrity before use
• Use controlled handling despite more robust construction and extreme length
• Not suitable for excessive force application
• Use guided extreme deep dilation technique
• Stop dilation immediately if resistance is encountered
• Exercise care near extreme deep vascular structures
• Exercise absolute concentration and attention with extreme reach applications
• Special training in handling ultra-long instruments required
• Regular inspection of shaft stability required
• Strictly follow reprocessing guidelines for reuse