Integra NeuroSciences™ Evolution Pole Mount Laser Level with Bracket INS400L

GUDID 10381780112228

The Pole Mount Laser Level device is provided with mounting bracket for use with Integra Pole Mount Assemblies. The Pole Mount Laser provides alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular catheter or lumbar catheter to an external ventricular drainage system.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780112228
• NIH Device Record Key: bb15d656-6374-4047-b9c8-04a24db7ae99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra NeuroSciences™ Evolution Pole Mount Laser Level with Bracket
• Version Model Number: INS400L
• Catalog Number: INS400L
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.
• Special Storage Condition, Specify: Between 0 and 0 *Exposure to water, dust, heat or sunlight can damage the laser. Do not drop the laser level device or subject it to stress; damage to laser can result.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780112228 [Primary]
HIBCC	M269INS400L1 [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

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