OSV II Lumbar Valve System 909711

GUDID 10381780034025

The Integra OSV II Lumbar hydrocephalus Valve System is an implantable device for controlled cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, the OSV II Lumbar Valve System is a variable resistance valve which maintains drainage rate close to the CSF secretion rate (20 ml/hr) within the physiological range of intracranial pressure (ICP). The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Lumboperitoneal shunt

• Primary Device ID: 10381780034025
• NIH Device Record Key: 68511181-6f71-476f-9a4d-2f74b10ef191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSV II Lumbar Valve System
• Version Model Number: 909711
• Catalog Number: 909711
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780034025 [Primary]
HIBCC	M2729097111 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092395

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: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2015-10-01

On-Brand Devices [OSV II Lumbar Valve System]

• 10381780034025: The Integra OSV II Lumbar hydrocephalus Valve System is an implantable device for controlled cer
• 10381780034018: The Integra OSV II Lumbar hydrocephalus Valve System is an implantable device for controlled cer