N/A

GUDID 10381780211082

Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal fluid (CSF) from an intraventricular catheter to a collection bag. The system can be used for external drainage, and the management of hydrocephalic shunt infections, or treatment of other cerebral conditions such as pre-operative or post-operative pressure monitoring of CSF to control increased intracranial pressure.

Integra Lifesciences Corporation

Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit

• Primary Device ID: 10381780211082
• NIH Device Record Key: 1a369e21-6544-4ca5-ae99-6ab0c952e701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: NL850500V
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780211082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932769

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: 2020-09-22
• Device Publish Date: 2017-02-14

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• 30381780490030: creos™ xenotape Absorbable Collagen Wound Dressing for Dental Surgery
• 10381780211082: Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal
• 10381780071273: Multi-Purpose Valve, Model: High Pressure 95-150mm H20 closing pressure