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Tissue Sealing Device(ENSEAL ) - India CDSCO Medical Device Registration

Tissue Sealing Device(ENSEAL ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000009_4553426d4d015b5f36ea6ffb16e6fc85_1134b2f3efc252c5c13ac4ecf7cb97ca. This device is marketed under the brand name Shears with Advanced Hemostasis . The license holder is Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Tissue Sealing Device(ENSEAL )
UID: IMP/MD/2020/000009_4553426d4d015b5f36ea6ffb16e6fc85_1134b2f3efc252c5c13ac4ecf7cb97ca

Brand Name

Shears with Advanced Hemostasis

Device Class

Class D

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 (Shears with Advanced Hemostasis ). 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, thoracic, and vascular procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels (Shears with Advanced Hemostasis ) up to and including 7 mm and tissue bundles

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Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

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Tissue Sealing Device(ENSEAL )

Brand: Shears with Advanced Hemostasis

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

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