Description

Cusco sterile vaginal speculum

Use: Device for gynaecological examination
Setting: Easy, lockable, noiseless
Transparent

 

Technical
information

Indications 
This examination is performed in order to view the macroscopic appearance of the uterine cervix and the vaginal mucosa as well as the cervico-vaginal secretions and to take samples. This procedure also protects the patient's hygiene.

Used materials 
Polyethylene: Bar - GPPS: Body

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

  • MD class : I
  • MD notified body : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

economic operator 

  • MANUFACTURER : DIDACTIC / 1800 route des bleuets, Le Mirlibut 76430 Et

Cusco sterile vaginal speculum

Use: Device for gynaecological examination
Setting: Easy, lockable, noiseless
Transparent

 

Indications 
This examination is performed in order to view the macroscopic appearance of the uterine cervix and the vaginal mucosa as well as the cervico-vaginal secretions and to take samples. This procedure also protects the patient's hygiene.

Used materials 
Polyethylene: Bar - GPPS: Body

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

  • MD class : I
  • MD notified body : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

economic operator 

  • MANUFACTURER : DIDACTIC / 1800 route des bleuets, Le Mirlibut 76430 Et

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