KRISTELLER flat Retractor 115x24mm Fig.2

KRISTELLER HOLDER • FLAT 115x24mm • FIG.2 • CE-CLASS I • ISO 13485:2016

Reinforced Flat Instrument Holder for Therapeutic Gynecological Procedures

The KRISTELLER Flat Holder Fig.2 (115x24mm) is a medical device of CE class I according to ISO 13485:2016. The extended flat design was specifically developed for therapeutic procedures and demanding diagnostic techniques requiring minimal tissue pressure with extended instrument stability.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Reinforced flat design 115x24mm – for therapeutic procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Reinforced flat jaw construction – minimal tissue pressure with stability
✔ Extended flat construction – optimal balance between function and gentleness
✔ Reinforced atraumatic jaw edges – maximum patient comfort
✔ Robust gripping mechanism – stable instrument fixation
✔ Ergonomic comfort handles – for optimal control during procedures
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Flat Holder Fig.2 115x24mm:

• Reinforced flat construction for therapeutic procedures
• Extended dimensions with flat profile for optimal instrument guidance
• Minimal tissue pressure even during extended procedures
• Ideal for demanding therapeutic interventions
• Perfectly matched to KRISTELLER Flat Speculum Fig.2

Fields of Application:

• Therapeutic procedures on cervix and portio
• Operative conizations
• Extended biopsy sampling
• Vessel occlusion during therapeutic procedures
• Holding therapeutic surgical instruments
• Assistance during complex colposcopic procedures
• Outpatient surgical gynecological procedures

Technical Specifications:

• Model: KRISTELLER Holder flat Fig.2
• Dimensions: 115mm length, 24mm jaw width
• Jaw length: 38mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Robust gripping and locking mechanism
• Jaw shape: Reinforced flat, extended, atraumatic
• Surface: High-gloss polished
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C

Important Safety Information:
• For professionals experienced in therapeutic gynecology only
• Special care required during positioning of extended flat holder
• Check stable fit and secure hold of instrument
• Only for therapeutic procedures with appropriate indication
• Regular inspection of stability and functionality recommended