Integra® 910110A

GUDID 30381780023719

The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Cerebrospinal fluid external drainage kit

• Primary Device ID: 30381780023719
• NIH Device Record Key: bdcfb17d-0335-4d39-b392-ef03f9afca3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: 910110A
• Catalog Number: 910110A
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• 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

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780023715 [Primary]
GS1	30381780023719 [Package]; Contains: 10381780023715; Package: BOX [6 Units]; In Commercial Distribution
HIBCC	M272910110A1 [Secondary]

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: 5
• Public Version Date: 2023-02-24
• Device Publish Date: 2015-10-01

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• M272ECCFS021: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
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• M27240M441: The T-shaped female electrode connecting cable is a reusable device used to connect the IntegraÂ
• M27240M401: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M391: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M381: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M371: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M361: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M351: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M341: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
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• M272ECCFS121: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS101: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS081: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS061: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS041: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF81: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF64161: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF641: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF61: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica