Tissue Sealing Device
- UID
- IMP/MD/2021/000490_3bfd6cf01cadc13ddb61b6965cccf528_81e8f47260ce7f32b699a2ed6e0f3a77
- Device class
- Class D
- Brand name
- Harmonic Synergy®
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- The ENSEAL X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (Harmonic Synergy®). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecologic, urologic and thoracic procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oophorectomies. The devices can be used on vessels (Harmonic Synergy®) up to and including 7 mm and tissue bundles
Tissue Sealing Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000490_3bfd6cf01cadc13ddb61b6965cccf528_81e8f47260ce7f32b699a2ed6e0f3a77. This device is marketed under the brand name Harmonic Synergy®. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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