HEGAR Uterus Dilator 11,0 mm

HEGAR UTERINE DILATOR • 11.0 MM • SINGLE INSTRUMENT • CE CLASS I • ISO 13485:2016

Precision Super Dilator for Special Gynecological Supermaximum Expansions

The HEGAR Uterine Dilator 11.0 mm is a medical device of CE Class I according to ISO 13485:2016. This single instrument in super size enables special cervical dilation for exceptional gynecological supermaximum surgeries with super instrumentation.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Directive 93/42/EEC)
✔ Super size 11.0 mm – for special supermaximum expansions
✔ 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 – optimal grip with super resistance
✔ Sterile packaged – individually for immediate use
✔ Reusable – when following reprocessing guidelines

Benefits of the HEGAR Uterine Dilator 11.0 mm:

• Super size for special gynecological supermaximum expansions
• Enables passage of super curettes and special instruments
• Important standard size for exceptional operative supermaximum procedures
• Specially reinforced construction for super tissue resistance

Areas of Application:

• Exceptional operative cervical dilation in special procedures
• Preparatory dilation for super operative hysteroscopies
• Therapeutic super maximum dilation for most extreme cervical stenosis
• Dilation prior to procedures with super instrumentation
• Exceptional gynecological supermaximum operations

Technical Specifications:

• Model: HEGAR Uterine Dilator
• Size: 11.0 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 highly specialized personnel in operative gynecology
• Use only for exceptional clinical indications after ultimate benefit-risk assessment
• Extremely slow and gradual dilation while ultimately monitoring tissue resistance
• Absolute caution with previously operated cervix, extensive scar formation or high-risk patients
• Check for microscopic damages and structural integrity before each use
• Follow reprocessing guidelines strictly for reuse