Tissue Sealing Device
- UID
- IMP/MD/2020/000009_3bfd6cf01cadc13ddb61b6965cccf528_4a935f03c384b493965a844163e23389
- Device class
- Class C
- Brand name
- Harmonic
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (Harmonic), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (Harmonic). The devices can be used on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures
Tissue Sealing Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000009_3bfd6cf01cadc13ddb61b6965cccf528_4a935f03c384b493965a844163e23389. This device is marketed under the brand name Harmonic. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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