PAVMED INC.

Address:200 Foxborough Boulevard,Foxborough,MA,02035,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

Clear

CarpX - 00860004588009 Catalog Number :

Device Description : The PAVmed CarpX is a sterile, single-use, bipolar high frequency electrosurgica The PAVmed CarpX is a sterile, single-use, bipolar high frequency electrosurgical device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during minimally invasive or general surgical procedures for tissue cutting, including the isolation and division of ligaments, tendons and fascia such as the transverse carpal ligament for the treatment of carpal tunnel syndrome.

Device Class : 2

Duns Number: 079825991

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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