OBWEGESER RETRACTOR • UPWARDS CURVED • 16x80MM • 24.0 CM • CE CLASS I • ISO 13485:2016

The Ultimate Instrument for Monumental Upward Retraction in Most Complex Craniofacial Surgery

The OBWEGESER Retractor upwards curved, 16x80mm, 24.0 cm is a Class I medical device according to ISO 13485:2016. These extraordinary dimensions of 16 mm width and 80 mm height represent the absolute limit for manual retraction instruments with upward function. Designed for the rarest and most complex procedures in extended skull base and facial surgery.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Directive 93/42/EEC)
✔ Ultra-Upwards retractor with maximum blade dimension
✔ Upward-curved design for extreme superior exposure
✔ High-strength surgical stainless steel 1.4435 – corrosion-resistant and biocompatible
✔ Biocompatibility tested according to ISO 10993
✔ Atraumatically polished edges for highest patient safety
✔ Maximum 24.0 cm length for access to deepest anatomical regions
✔ Sterilizable and reusable under protocol

Advantages of the Monumental Upwards Retractor:

• Ultimate Surface Control: 16x80 mm provides unparalleled control over large soft tissue volumes
• Precise Upward Retraction: Specially calculated curvature for optimal superior force distribution
• Extreme Load Capacity: Construction for highest vertical traction forces at depth
• Maximum Reach: 24.0 cm for exposure of entire anterior and middle skull base
• Unique Application: Specifically for borderline situations in craniofacial surgery

Technical Specifications:

• Model: OBWEGESER RETRACTOR Monumental
• Total Length: 24.0 cm
• Blade Dimensions: 16 mm (width) x 80 mm (height)
• Construction: Forged single piece with precise upward curvature
• Tip: Broad-surface rounded, completely atraumatic
• Material: Stainless steel 1.4435
• Shape: Monumental upward-curved blade with reinforced base
• Handle: Industrial rake handle for maximum force transmission
• Surface: High-gloss polished and passivated
• Special Feature: Highest dimension ever manufactured for upward retraction
• Risk Class: I according to Directive 93/42/EEC

Fields of Application:

• Resection of gigantic tumors of the entire skull base
• Complex reconstructions following panfacial trauma
• Approaches to clivus, sella, and cavernous sinus via combined approaches
• Revision surgeries for extensive craniofacial malformations
• Decompression of multiple neurovascular structures at the skull base

CRITICAL SAFETY NOTES:
• EXCLUSIVELY FOR A WORLDWIDE PREDEFINED EXPERT GROUP (<20 SURGEONS)
• APPLICATION ONLY IN CERTIFIED MAXIMUM CARE CENTERS
• REQUIRES WRITTEN APPROVAL AND ETHICS VOTE PER INDIVIDUAL CASE
• BEFORE EACH USE: NON-DESTRUCTIVE MATERIAL TESTING (X-RAY/EDDY CURRENT)
• BIMANUAL APPLICATION BY TWO EXPERIENCED SURGEONS MANDATORY
• DEFINED SERVICE LIFE: 2 YEARS OR 25 STERILIZATION CYCLES
• DISCARD IMMEDIATELY UPON ANY DEVIATION FROM TARGET CONDITION
• NO REPAIR POSSIBLE – RETURN TO MANUFACTURER IN CASE OF INCIDENT