Tissue Sealing Device - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Tissue Sealing Device

UID: IMP/MD/2020/000009_3bfd6cf01cadc13ddb61b6965cccf528_4a935f03c384b493965a844163e23389

Brand Name

Harmonic

License Holder

Johnson & Johnson Private Limited

Device Class

Class C

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

Class C

Dilating Tip trocars

Brand: Harmonic

Johnson & Johnson Private Limited

Class C

Brand: PROLENE*

Class D