Intramedullary Nail System - India CDSCO Medical Device Registration

Intramedullary Nail System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_a0470d33dd646aec07464bc35a718ee4_e1294fe95cb7d9c4334bd317262345fc. This device is marketed under the brand name JOURNEY. The license holder is Smith & Nephew Healthcare 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

Intramedullary Nail System

UID: IMP/MD/2018/000076_a0470d33dd646aec07464bc35a718ee4_e1294fe95cb7d9c4334bd317262345fc

Brand Name

JOURNEY

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

"Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated."

Class C

Screws

Class C

Moisture Responsive Catheter Dressing

Brand: IV3000

Class B

Transparent dressing

Brand: IV3000

Class B