KRISTELLER flat Retractor 115x22mm Fig.1

KRISTELLER HOLDER • FLAT 115x22mm • FIG.1 • CE-CLASS I • ISO 13485:2016

Flat Precision Instrument Holder for Extended Gynecological Procedures

The KRISTELLER Flat Holder Fig.1 (115x22mm) is a medical device of CE class I according to ISO 13485:2016. The flat design was specifically developed for extended diagnostic and therapeutic procedures requiring minimal tissue pressure and optimal instrument guidance.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Flat precision design 115x22mm – for extended procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Flat jaw construction – minimal tissue pressure
✔ Extended but flat construction – optimal balance
✔ Atraumatic jaw edges – maximum patient comfort
✔ Precise gripping mechanism – secure instrument fixation
✔ Ergonomic handles – for optimal control
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Flat Holder Fig.1 115x22mm:

• Flat construction for minimal tissue pressure
• Extended dimensions with flat profile
• Optimal instrument guidance during therapeutic procedures
• Ideal for procedures with sensitive anatomy
• Perfectly matched to KRISTELLER Flat Speculum Fig.1

Fields of Application:

• Extended colposcopic examinations
• Therapeutic procedures on cervix and portio
• Precise biopsy sampling
• Vessel occlusion during sensitive procedures
• Holding diagnostic and therapeutic instruments
• Assistance during outpatient surgical procedures
• Complex cytological smear procedures

Technical Specifications:

• Model: KRISTELLER Holder flat Fig.1
• Dimensions: 115mm length, 22mm jaw width
• Jaw length: 35mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Precise gripping and locking mechanism
• Jaw shape: 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 extended gynecological diagnostics only
• Special care required during positioning of flat holder
• Check proper fit and secure hold of instrument
• Only for procedures with appropriate indication
• Regular inspection of functionality recommended