Integra® External CSF Drainage System Replacement Bag INS8700

GUDID 30381780071017

The Hermetic Plus External CSF Drainage Systems provides a sterile fluid path resistant to microbial particles. The systems are used to drain cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainage bag. System components facilitate CSF drainage, fluid injection, CSF sampling and Intracranial Pressure (ICP) monitoring.

Integra Lifesciences Corporation

Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit Lumbar cerebrospinal fluid drainage catheterization kit

• Primary Device ID: 30381780071017
• NIH Device Record Key: ceb3ffbc-b6ec-49f0-bccf-ed12f8b2ced0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® External CSF Drainage System Replacement Bag
• Version Model Number: INS8700
• Catalog Number: INS8700
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780071013 [Primary]
GS1	30381780071017 [Package]; Contains: 10381780071013; Package: BOX [5 Units]; In Commercial Distribution
HIBCC	M269INS87001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030289

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

Devices Manufactured by Integra Lifesciences Corporation

• 10381780537434 - Hermetic Plus™: 2024-07-08 Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Sites
• 10381780537502 - Integra®: 2024-07-08 Integra® External Drainage System
• 10381780537519 - Integra®: 2024-07-08 Integra® External Drainage System
• 10381780537526 - Hermetic™: 2024-07-08 Hermetic™ External CSF Drainage System with Pressure Tubing
• 10381780252979 - Budde®: 2024-07-08 Budde® 1/4" X 4" Curved
• 10381780537540 - Budde®: 2024-07-08 Budde® 3/8" X 4" Curved
• 10381780537557 - Budde®: 2024-07-08 Budde® 5/8" X 4" Curved
• 10381780537564 - Budde®: 2024-07-08 Budde® 3/4" X 4" Curved