Tricuspid Band Sizer Set - India CDSCO Medical Device Registration

Tricuspid Band Sizer Set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000064_da20694617b3689dfc9729984f4f30bc_bf074c193a009b13e0af25f765920184. This device is marketed under the brand name Aortic Punch. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Tricuspid Band Sizer Set

UID: IMP/MD/2019/000064_da20694617b3689dfc9729984f4f30bc_bf074c193a009b13e0af25f765920184

Brand Name

Aortic Punch

License Holder

India Medtronic Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The sizers are to be used to size a patient's tricuspid valve annulus in order to select the proper size of the Tri-Ad™ 2.0 Adams tricuspid band. Do not use sizers from other Medtronic annuloplasty products or other manufacturers to size the Tri-Ad™ 2.0 Adams tricuspid band. Use of other sizers could result in selecting the wrong band size

Class B

Co-Axial Umbilical

Brand: Aortic Punch

India Medtronic Private Limited

Class B

Class C