Electrosurgical diathermy system return electrode, single-use, non-sterile
Australia TGA ARTG Registered Device · Koala Medical Pty Ltd · Bio Protech Inc · Class IIb · Started February 07, 2017
Good Name: Koala Medical Pty Ltd - Electrosurgical diathermy system return electrode, single-use, non-sterile
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- February 07, 2017
- Effective Date
- February 07, 2017
- Name
- Bio Protech Inc
- Country
- South Korea
- Address
- Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do
A non-sterile non-active dispersive conductor intended to be fastened to a patient using an adhesive gel pad and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. The Pro Plate is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached cables but may be provided without one allowing the use of a reusable cable. This is a single-use device.
Access comprehensive regulatory information for Electrosurgical diathermy system return electrode, single-use, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Koala Medical Pty Ltd, manufactured by Bio Protech Inc in South Korea. The device registration started on February 07, 2017.
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