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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_0bcf4e41d63715f3e2c4e77ad7d16eba. 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_0bcf4e41d63715f3e2c4e77ad7d16eba

Brand Name

Shears with Advanced Hemostasis

Device Class

Class D

Approving Authority

CDSCO

Product Information

The ENSEALยฎ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar instrument for use with an electrosurgical generator. It is intended for use during open general and gynecological surgery to cut and seal vessels, cut, grasp and dissect during surgery. Indications for use include open general, gynecological surgical procedures (Shears with Advanced Hemostasis ), or any procedure where vessel ligation (Shears with Advanced Hemostasis ), tissue grasping and dissection is performed. The devices can be used on vessels up to (Shears with Advanced Hemostasis ) 7 mm and bundles as large as will fit in the jaws of the instruments

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