VENCLOSE INC

Address:2570 N 1st St Fl 2 # 221,San Jose,CA,95131,US

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Filters

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) (10)

Premarket Exempt

Clear

Venclose System EVSRF Catheter - 00858254006008 Catalog Number :

Device Description : Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm

Device Class :

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System EVSRF Catheter - 00858254006015 Catalog Number :

Device Description : Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm

Device Class :

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System digiRF Generator - 00858254006022 Catalog Number :

Device Description : Radiofrequency Ablation (RFA) Generator

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Foot Pedal - 00858254006039 Catalog Number :

Device Description : Foot Pedal

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Power Cord - 00858254006046 Catalog Number :

Device Description : Power Cord, US

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Power Cord - 00858254006053 Catalog Number :

Device Description : Power Cord, Germany, Finland, Netherlands, Spain, Turkey, France, Belgium, Czech Power Cord, Germany, Finland, Netherlands, Spain, Turkey, France, Belgium, Czech Republic, Poland

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Power Cord - 00858254006060 Catalog Number :

Device Description : Power Cord, UK, Hong Kong

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Power Cord - 00858254006077 Catalog Number :

Device Description : Power Cord, China

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Power Cord - 00858254006084 Catalog Number :

Device Description : Power Cord, Australia, New Zealand

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Venclose System Power Cord - 00858254006091 Catalog Number :

Device Description : Power Cord, Brazil

Device Class : 2

Duns Number: 085838983

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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