Electrosurgical Cutting & Coagulation Device
- UID
- IMP/MD/2018/000084_55eaaad0b9845a9fce4b4e6e04ee95c2_3b33fdf7e8584285f2528d9fccc00d71
- Device class
- Class C
- Brand name
- Thunder Beat
- Approving authority
- CDSCO
- Product information
- The THUNDERBEAT hand instrument is intended to be used with the Ultrasonic Generator (Thunder Beat), the Electrosurgical Generator (Thunder Beat), and the THUNDERBEAT Transducer, (Thunder Beat). Seal & Cut mode: The THUNDERBEAT hand instrument when used in combination with the Seal & Cut mode is indicated for open general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (Thunder Beat) etc) or in any procedure in which cutting, vessel ligation (Thunder Beat), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (Thunder Beat), tissue bundles, and lymphatics. Seal mode: The THUNDERBEAT hand instrument when used in combination with the Seal mode is indicated for open general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (Thunder Beat) etc) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (Thunder Beat), tissue bundles, and lymphatics. The THUNDERBEAT hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Electrosurgical Cutting & Coagulation Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000084_55eaaad0b9845a9fce4b4e6e04ee95c2_3b33fdf7e8584285f2528d9fccc00d71. This device is marketed under the brand name Thunder Beat. The license holder is Olympus Medical Systems India Private Limited ,A-Block, 2nd Floor, Hafed Warehouse Complex, New Anaj Mandi, Khandsa Road ,Gurgaon Haryana ,122001 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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