Polytetrafluoroethylene Intra-cardiac patch - India CDSCO Medical Device Registration

Polytetrafluoroethylene Intra-cardiac patch is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000177_c14617106143bda64a052506104527c3_352588a98a8e9c4ed932c47f650c7a6f. This device is marketed under the brand name PTFE. The license holder is M/S Microtrol Sterilisation Services Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Polytetrafluoroethylene Intra-cardiac patch

UID: MFG/MD/2021/000177_c14617106143bda64a052506104527c3_352588a98a8e9c4ed932c47f650c7a6f

Brand Name

PTFE

License Holder

M/S Microtrol Sterilisation Services Pvt Ltd

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

PTFE Pledgets used in various applications for general, vascular and cardiac surgery. Pledgets are used as buttresses under sutures when there is a possibility of sutures tearing through tissue. PTFE Pledgets are indicated for the purposes of tissue approximation, retraction, and as a temporary or permanent ligature

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