Torque Wrench - India CDSCO Medical Device Registration

Torque Wrench is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000339_b9c7281608c8fc03b9770829425865dc_cd17c14945449950d1d74ee458529f8d. This device is marketed under the brand name Brio™ Patient Controller . The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Torque Wrench

UID: IMP/MD/2021/000339_b9c7281608c8fc03b9770829425865dc_cd17c14945449950d1d74ee458529f8d

Brand Name

Brio™ Patient Controller

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

This neurostimulation system is indicated for unilateral or bilateral stimulation of the thalamus, internal globus pallidus (Brio™ Patient Controller ), or subthalamic nucleus (Brio™ Patient Controller ) in patients with levodopa-responsive Parkinson’s disease. The torque wrench is used to tighten the setscrew on the connector assemblies of the IPG and extension