INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Address:2905 ROUTE DES DOLINES,Sophia Antipolis CEDEX Alpes-Maritimes,FR

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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

Shunt, central nervous system and components (JXG) (6)

Premarket Exempt

No Yes

Clear

Contour-Flex Valve and Shunt System - 10381780457541 Catalog Number : CFRH

Device Description : Contour-Flex Valve Unit, Regular, High Pressure for ventricular shunting of cere Contour-Flex Valve Unit, Regular, High Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Contour-Flex Valve and Shunt System - 10381780457558 Catalog Number : CFRL

Device Description : Contour-Flex Valve Unit, Regular, Low Pressure for ventricular shunting of cereb Contour-Flex Valve Unit, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Contour-Flex Valve and Shunt System - 10381780457565 Catalog Number : CFRM

Device Description : Contour-Flex Valve Unit, Regular, Medium Pressure for ventricular shunting of ce Contour-Flex Valve Unit, Regular, Medium Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Contour-Flex Valve and Shunt System - 10381780457572 Catalog Number : CFSH

Device Description : Contour-Flex Valve Unit, Small, High Pressure for ventricular shunting of cerebr Contour-Flex Valve Unit, Small, High Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Contour-Flex Valve and Shunt System - 10381780457589 Catalog Number : CFSL

Device Description : Contour-Flex Valve Unit, Small, Low Pressure for ventricular shunting of cerebro Contour-Flex Valve Unit, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Contour-Flex Valve and Shunt System - 10381780457596 Catalog Number : CFSM

Device Description : Contour-Flex Valve Unit, Small, Medium Pressure for ventricular shunting of cere Contour-Flex Valve Unit, Small, Medium Pressure for ventricular shunting of cerebrospinal fluid.

Device Class : 2

Duns Number: 531408342

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

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