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Ablation Device(Harmonic ACE ) - India CDSCO Medical Device Registration

Ablation Device(Harmonic ACE ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000009_7fa301a2d374b569e57bad7cfcdb8978_a246ac65508ddc604e25f116837b4f1e. 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
Ablation Device(Harmonic ACE )
UID: IMP/MD/2020/000009_7fa301a2d374b569e57bad7cfcdb8978_a246ac65508ddc604e25f116837b4f1e

Brand Name

Shears with Advanced Hemostasis

Device Class

Class D

Approving Authority

CDSCO

Product Information

The HARMONIC ACEยฎ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (Shears with Advanced Hemostasis ) and other open and endoscopic procedures.

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