Contour-Flex Valve and Shunt System 11855

GUDID 10381780032878

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 Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 10381780032878
• NIH Device Record Key: 00c25b9a-0c34-48e1-ab6b-4a3e705b8239
• Commercial Distribution Discontinuation: 2021-01-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contour-Flex Valve and Shunt System
• Version Model Number: 11855
• Catalog Number: 11855
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780032878 [Primary]
HIBCC	M272118551 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033698

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-20
• Device Publish Date: 2015-10-01

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

• 10381780032885: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032878: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032861: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780457534: Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780457527: Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal flui
• 10381780457510: Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780457503: Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal flui
• 10381780457497: Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fl
• 10381780457480: Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid
• 10381780457442: Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal flui
• 10381780457435: Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fl
• 10381780457428: Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid
• 10381780457411: Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780457404: Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal flui
• 10381780457398: Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780457381: Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal flui
• 10381780457374: Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fl
• 10381780457367: Contour-Flex Valve System, Regular, Low Pressure for ventricular shunting of cerebrospinal fluid
• 10381780457350: Contour-Flex Valve System, Small, High Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780457343: Contour-Flex Valve System, Small, Medium Pressure for ventricular shunting of cerebrospinal flui
• 10381780457336: Contour-Flex Valve System, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780036838: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780036821: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780036814: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780036807: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780036791: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780036784: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033141: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033134: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033127: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033066: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033059: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033042: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033035: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033028: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780033011: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• M272125101: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032939: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032922: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032915: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032908: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032892: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032854: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032847: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032830: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032823: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032816: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780032809: The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral co
• 10381780457596: Contour-Flex Valve Unit, Small, Medium Pressure for ventricular shunting of cerebrospinal fluid.
• 10381780457589: Contour-Flex Valve Unit, Small, Low Pressure for ventricular shunting of cerebrospinal fluid.