HEGAR Uterus Dilator 13.5 mm

HEGAR UTERINE DILATOR • 13.5 MM • SINGLE INSTRUMENT • CE CLASS I • ISO 13485:2016

Precision Transition Hyper Dilator for Maximally Extended Gynecological Special Expansions

The HEGAR Uterine Dilator 13.5 mm is a medical device of CE Class I according to ISO 13485:2016. This single instrument in transition hyper size enables gentle dilation between hyper standard sizes for optimal tissue adaptation in maximally extended gynecological hypermaximum surgeries.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Directive 93/42/EEC)
✔ Transition hyper size 13.5 mm – for gentle hyper size transitions
✔ 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 precision tip – for maximum tissue preservation
✔ Highly reinforced ergonomic safety ring handle – secure grip with hyper resistance
✔ Sterile packaged – individually for immediate use
✔ Reusable – when following reprocessing guidelines

Benefits of the HEGAR Uterine Dilator 13.5 mm:

• Optimal transition size between 13.0 mm and 14.0 mm
• Enables particularly gentle dilation for maximally extended special expansions
• Reduces tissue resistance during passage of hyper-large special instruments
• Ideal for preparation of maximally extended operative hypermaximum procedures

Areas of Application:

• Maximally extended operative cervical dilation in hypermaximum procedures
• Preparatory dilation for maximally extended operative hypermaximum hysteroscopies
• Therapeutic hyper dilation for most extreme cervical stenosis
• Dilation prior to procedures with maximally extended hyper instrumentation
• Maximally extended gynecological hypermaximum operations

Technical Specifications:

• Model: HEGAR Uterine Dilator
• Size: 13.5 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: Highly 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 special 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