KRISTELLER Retractor deep 115x14mm Fig.00

KRISTELLER HOLDER • DEEP-CONCAVE 115x14mm • FIG.00 • CE-CLASS I • ISO 13485:2016

Ultra-Narrow Deep-Concave Instrument Holder for Maximum Sensitivity Gynecological Procedures

The KRISTELLER Deep-Concave Holder Fig.00 (115x14mm) is a medical device of CE class I according to ISO 13485:2016. This ultra-narrow holder with deep-concave construction was specifically developed for highly sensitive diagnostic and therapeutic procedures in virginal patients, children and in extreme pain conditions.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Ultra-narrow deep-concave design 115x14mm – for maximum sensitivity
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Deep-concave jaw construction – maximum gentleness with minimal tissue pressure
✔ Ultra-narrow configuration – for virginal and pediatric anatomy
✔ Strongly conical jaw ends – atraumatic application
✔ Micro-precision mechanism – extremely fine locking
✔ Spring-tip jaws – minimal tissue trauma
✔ Ergonomic micro-grips – for maximum sensitivity
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Deep-Concave Holder Fig.00 115x14mm:

• Deep-concave construction for maximum tissue preservation
• Ultra-narrow for children and virginal patients
• Minimal tissue pressure with secure instrument guidance
• Specifically for highly anxious and traumatized patients
• Ideal for pediatric gynecology

Fields of Application:

• Biopsy sampling in children and virginal patients
• Vessel occlusion during highly sensitive procedures
• Holding finest diagnostic instruments
• Assistance during pediatric colposcopic procedures
• Therapeutic procedures with preserved hymenal integrity
• Examinations after sexual violence
• Diagnostics for congenital malformations

Technical Specifications:

• Model: KRISTELLER Holder deep-concave Fig.00
• Dimensions: 115mm length, 14mm jaw width
• Jaw length: 25mm
• Special feature: Deep-concave jaw construction with spring tips
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Micro-precision gripping mechanism
• Jaw shape: Ultra-narrow, deep-concave, spring-tipped
• Surface: High-gloss polished
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C

Important Safety Information:
• For professionals specialized in pediatric and psychosomatic gynecology only
• Extremely sensitive and trauma-aware examination technique required
• Comprehensive education and explicit consent essential
• Discontinue use immediately at slightest resistance
• Specifically for use in children and highly traumatized patients