Australia TGA ARTG recordEvacuator, smoke, surgical
Australia TGA ARTG Registered Device · Koala Medical Pty Ltd · Bio Protech Inc · Class I · Started November 08, 2019
Good Name: Koala Medical Pty Ltd - Evacuator, smoke, surgical
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 08, 2019
- Effective Date
- November 08, 2019
- Name
- Bio Protech Inc
- Country
- South Korea
- Address
- Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do
A device that is used to capture the smoke generated during open surgical procedures in which there is tissue ablation, e.g. laser surgery, electrocautery or electrosurgery. It captures the smoke plume composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue near its origin before the smoke becomes air-dispersed and enters the respiratory tracts of the surgical team. The device may also be used during closed surgical procedures, e.g. endoscopy or laparoscopy, to clear smoke from the surgeon's field of view.
Access comprehensive regulatory information for Evacuator, smoke, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Koala Medical Pty Ltd, manufactured by Bio Protech Inc in South Korea. The device registration started on November 08, 2019.
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