Contour-Flex Valve and Shunt System 11812

GUDID 10381780032816

The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventriculo-peritoneal/atrial shunt
Primary Device ID10381780032816
NIH Device Record Keye494ad1b-554d-417f-b38c-f7d58a12f001
Commercial Distribution Discontinuation2021-01-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameContour-Flex Valve and Shunt System
Version Model Number11812
Catalog Number11812
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780032816 [Primary]
HIBCCM272118121 [Secondary]

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-20
Device Publish Date2015-10-01

On-Brand Devices [Contour-Flex Valve and Shunt System]

10381780032885The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032878The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032861The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780457534Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
10381780457527Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal flui
10381780457510Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
10381780457503Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal flui
10381780457497Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fl
10381780457480Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid
10381780457442Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal flui
10381780457435Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fl
10381780457428Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid
10381780457411Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
10381780457404Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal flui
10381780457398Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
10381780457381Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal flui
10381780457374Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fl
10381780457367Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid
10381780457350Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
10381780457343Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal flui
10381780457336Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
10381780036838The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780036821The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780036814The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780036807The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780036791The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780036784The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033141The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033134The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033127The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033066The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033059The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033042The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033035The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033028The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780033011The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
M272125101The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032939The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032922The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032915The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032908The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032892The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032854The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032847The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032830The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032823The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032816The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780032809The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
10381780457596Contour-Flex Valve Unit, Small, Medium Pressure for ventricular shunting of cerebrospinal fluid.
10381780457589Contour-Flex Valve Unit, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.

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