Integra NeuroSciences™ Evolution Pole Mount Assembly INS400CM

GUDID 10381780112211

The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular or lumbar catheter to an external CSF drainage system. This Integra Pole Mount is provided with a laser leveling device and an optional line level. The laser level is attached via a bracket.

Integra Lifesciences Corporation

Ventricular cerebrospinal fluid drainage kit

• Primary Device ID: 10381780112211
• NIH Device Record Key: 1af18d7f-0e4e-4467-ba8e-7c458317e95d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra NeuroSciences™ Evolution Pole Mount Assembly
• Version Model Number: INS400CM
• Catalog Number: INS400CM
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• 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
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• 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
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• 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
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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
• 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	10381780112211 [Primary]
HIBCC	M269INS400CM1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062599

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

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

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 [Integra NeuroSciences™ Evolution Pole Mount Assembly]

• 10381780112266: The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage a
• 10381780112259: The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage a
• 10381780112242: The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage a
• 10381780112211: The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage a
• 10381780112204: The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage a