Integra AccuDrain™ Laser Level INS8902

GUDID 10381780072171

ACCUDRAIN LASER The AccuDrain Laser Level device is provided with a mounting bracket for use with Integra AccuDrain external CSF drainage systems. The AccuDrain Laser Level is an alignment tool for the AccuDrain drainage system. AccuDrain drainage systems are used for draining cerebrospinal fluid from an intraventricular catheter or lumbar catheter to an external drainage system.

Integra Lifesciences Corporation

Ventricular cerebrospinal fluid drainage kit

• Primary Device ID: 10381780072171
• NIH Device Record Key: 8e983d37-db3f-4384-9d70-40ba5e3879c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra AccuDrain™ Laser Level
• Version Model Number: INS8902
• Catalog Number: INS8902
• 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
• 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
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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780072171 [Primary]
HIBCC	M269INS89021 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042825

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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