ISRAEL RETRACTOR WIDTH SERRATED HANDLE 6 PRONGS 50MM X 60MM 25,0CM

ISRAEL RETRACTOR • 6 PRONGS • 50x60MM • 25.0 CM • CE CLASS I • ISO 13485:2016

The Definitive Heavy-Duty Retraction Instrument for Most Complex Oncological and Reconstructive Major Procedures

The ISRAEL Retractor with 6 prongs, 50x60mm, 25.0 cm is a Class I medical device according to ISO 13485:2016. This instrument marks the absolute limit of what is technically feasible in manual retraction. With a record area of 50x60 mm, six massive prongs, and a length of 25 cm, it is designed exclusively for the most demanding scenarios where maximum holding power and exposure beyond conventional surgical limits are required.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Regulation (EU) 2017/745)
✔ ISRAEL master design with super-heavy, ergonomic rake handle
✔ 6 oversized prongs on record area (50x60 mm) for ultimate biomechanical anchorage
✔ High-strength surgical premium stainless steel 1.4435/316LVM (vacuum melted)
✔ Biocompatibility tested according to ISO 10993
✔ Construction following aerospace principles for maximum load capacity
✔ Maximum length of 25.0 cm for deepest and most extensive surgical fields
✔ Autoclavable and reusable under documented maintenance protocol

Advantages of the ISRAEL Retractor (6 prongs, 50x60mm):

• Biomechanical Supremacy: Six prongs on this area simulate an almost flat support and generate a holding power that enters the category of surgical levers and retractor systems.
• For Mobilizing Fixed Masses: Designed for retracting and mobilizing extremely large, fixed tumor masses, scarred-adherent organ blocks, or for exposing the entire retroperitoneum.
• Redundancy and Safety: The 6-prong design provides inherent redundancy; even under extreme load, the holding function is maintained by the remaining prongs.
• Final Manual Option Before Mechanical Retraction: Enables, in selected cases, the avoidance of using self-retaining retractor systems with their specific risks.
• Precision Tool for Specialists: Allows the experienced surgeon to navigate the fine line between necessary maximum force and still controllable manual dosing.

Technical Specifications:

• Model: ISRAEL Retractor with Rake Handle (Master-Retractor)
• Type: 6-prong, record area
• Blade Dimensions: Approx. 50 mm (width) x 60 mm (height)
• Total Length: 25.0 cm
• Handle: Super-heavy, deeply textured Rake Handle for bimanual force control
• Prong Shape: Six parallel, extremely massive prongs (standard sharp)
• Material: High-strength surgical premium stainless steel 1.4435 / 316LVM
• Surface: High-gloss polished, electropolished, and coated for minimal adhesion
• Processing: Autoclavable up to 135°C. Mandatory: Documented single-instrument protocol from OR table release to sterilization.
• Special Feature: The ultimate manual retraction instrument for borderline situations in surgery
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Fields of Application (Extremely Limited Indication):

• Radical oncological multivisceral resections with en bloc removal of tumor and surrounding structures
• Complex revision and salvage procedures following multiple previous surgeries and radiation
• Surgery on the thoraco-abdominal aorta and its main branches for maximum exposure
• Removal of extremely large intra-abdominal or retroperitoneal tumors (>20 cm)
• Special orthopedic tumor surgery with soft tissue involvement (e.g., pelvic resections)

MOST CRITICAL NOTES AND SAFETY PROTOCOLS:
• FOR USE BY A HANDFUL OF QUALIFIED REFERENCE SURGEONS WITH PROVEN EXPERTISE IN MAJOR SURGERY ONLY.
• NOT A GENERAL SURGICAL INSTRUMENT. Use only following interdisciplinary case conference and written justification.
• PRE-OPERATIVE INSPECTION WITH CERTIFICATE MANDATORY: Before each use, the instrument must be released by the certified instrument service. Visual and functional inspection under magnification is non-negotiable.
• APPLICATION: Requires special technique and often two surgeons for control. The risk of catastrophic tissue damage from improper use is extremely high.
• REPROCESSING AND MAINTENANCE: The instrument is subject to an individualized maintenance contract with fixed service intervals and an absolute service life limitation.
• DISCARD POLICY: The instrument is automatically discarded after a manufacturer-defined maximum number of sterilization cycles or usage hours, regardless of visual condition. Following any incident (drop, unusual stress), it must be locked immediately. Repair is excluded.