Electrosurgical Cutting & Coagulation Device - India CDSCO Medical Device Registration

Product Information

The THUNDERBEAT Open Fine Jaw 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 Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (Thunder Beat) 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. This mode is also indicated for open ENT procedure in adults (Thunder Beat) for only ligation (Thunder Beat) of vessels, lymphatics and tissue bundles 2-3 mm *1 away from unintended thermally sensitive structures such as nerves and parathyroid glands. Seal mode: The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (Thunder Beat) 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. This mode is also indicated for open ENT procedure in adults (Thunder Beat) for sealing of vessels, lymphatics and tissue bundles 2-3 mm *1 away from unintended thermally sensitive structures such as nerves and parathyroid glands. The THUNDERBEAT Open Fine Jaw 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