KRISTELLER Specula large version 135x36mm

KRISTELLER SPECULUM LARGE VERSION • 135X36MM • FIG. 0 • CE CLASS I • ISO 13485:2016

Professional speculum for demanding gynecological procedures

The Kristeller speculum in large version (135x36 mm) according to Figure 0 is a surgical instrument of CE class I according to ISO 13485:2016. Specifically developed for demanding gynecological procedures, the speculum provides optimal visibility and secure operation during complex procedures.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (MDR 2017/745)
✔ Large-scale dimensions 135x36 mm
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Reinforced construction – for stable hold during demanding procedures
✔ Atraumatic edges – for optimal patient comfort
✔ Ergonomic handles – for precise control
✔ Sterilizable – multiple times via steam, plasma or heat
✔ Robust premium construction – for maximum service life

Benefits of the Kristeller Speculum Large Version:

• Large dimensions for optimal visibility in complex procedures
• Reinforced construction for maximum stability
• Atraumatic design for patient-friendly application
• Precise handling even during demanding procedures

Areas of Application:

• Complex gynecological operations
• Oncological gynecological procedures
• Advanced diagnostic procedures
• Specialized gynecological surgery
• Operating room applications

Technical Specifications:

• Model: Kristeller Speculum Large Version
• Size: 135 mm length, 36 mm width
• Configuration: Figure 0
• Material: Surgical Steel 1.4021
• Type: Reusable (multiple use)
• Mechanism: Precision guidance
• Risk Class: I according to MDR 2017/745
• Sterilization: Sterilizable (steam, plasma, heat)

Important Safety Information:
• For experienced gynecological-surgical personnel only
• Special care required during application in complex cases
• Inspect for damage before each use
• Regular maintenance recommended