MoniTorr ICP™ External CSF Drainage and Monitoring System INS1100

GUDID 10381780071037

The MoniTorr ICP External CSF Drainage and Monitoring System provides a simple to use, closed system for the drainage of CSF from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick, and accurate alignment with the patient and secure, positive or negative pressure level setting.

Integra Lifesciences Corporation

Lumbar cerebrospinal fluid drainage kit

• Primary Device ID: 10381780071037
• NIH Device Record Key: b8b33f26-a09d-4996-af35-b12884db40aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoniTorr ICP™ External CSF Drainage and Monitoring System
• Version Model Number: INS1100
• Catalog Number: INS1100
• 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: false
• 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: 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
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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
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• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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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
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780071037 [Primary]
GS1	10381780542223 [Primary]
HIBCC	M269INS11001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022554

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: 2015-09-22

On-Brand Devices [MoniTorr ICP™ External CSF Drainage and Monitoring System]

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• 10381780070887: The MonitTorr ICP Exteral CSF Drainage and Monitoring System is designed to provide a simple to
• 10381780070863: The MoniTorr ICP External CSF Drainage and Monitoring System is designed to provide a simple to
• 10381780070856: The MoniTorr ICP External CSF Drainage and Monitoring System is designed to provide a simple to