HEGAR Uterus Dilator 8.5 mm

HEGAR UTERINE DILATOR • 8.5 MM • SINGLE INSTRUMENT • CE CLASS I • ISO 13485:2016

Precision Ultramaximum Dilator for Extremely Extended Operative Cervical Dilation

The HEGAR Uterine Dilator 8.5 mm is a medical device of CE Class I according to ISO 13485:2016. This single instrument in ultramaximum size enables extremely extended cervical dilation for special gynecological maximum surgeries with ultralarge instrumentation.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Directive 93/42/EEC)
✔ Ultramaximum size 8.5 mm – for extremely extended operative procedures
✔ High-quality stainless steel 1.4301 – rust-free, biocompatible and autoclavable
✔ Tested biocompatibility according to ISO 10993 – guaranteed tissue compatibility
✔ Clear double-sided size marking – easy identification
✔ Ultra-atraumatic special tip – for maximum tissue preservation
✔ Reinforced ergonomic safety ring handle – secure grip with high resistance
✔ Sterile packaged – individually for immediate use
✔ Reusable – when following reprocessing guidelines

Benefits of the HEGAR Uterine Dilator 8.5 mm:

• Ultramaximum size for special operative maximum expansions
• Enables passage of ultralarge curettes and special instruments
• Gentle transition dilation between 8.0 mm and 9.0 mm
• Specially reinforced construction for high tissue resistance

Areas of Application:

• Extremely extended operative cervical dilation in special procedures
• Preparatory dilation for ultralarge operative hysteroscopies
• Therapeutic maximum dilation for extreme cervical stenosis
• Dilation prior to procedures with ultralarge instrumentation
• Special gynecological maximum operations

Technical Specifications:

• Model: HEGAR Uterine Dilator
• Size: 8.5 mm
• Material: Surgical Steel 1.4301
• Length: Standard 20 cm (clinical working length)
• Type: Reusable
• Marking: Double-sided size indication
• Tip design: Ultra-atraumatic, precisely curved
• Handle design: Reinforced ergonomic with safety rings
• Risk Class: I according to Directive 93/42/EEC
• Sterilization: Suitable for steam sterilization (autoclave)

Important Safety Information:
• EXCLUSIVELY for specialized personnel in operative gynecology
• Use only for special clinical indications after strictest benefit-risk assessment
• Extremely gradual dilation while most strictly monitoring tissue resistance
• Absolute caution with previously operated cervix, scar formation or risk patients
• Check for damages and structural integrity before each use
• Follow reprocessing guidelines strictly for reuse