Hermetic Plus™ INS8301

GUDID 10381780537434

Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Sites

Integra Lifesciences Corporation

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

• Primary Device ID: 10381780537434
• NIH Device Record Key: f1bdbfb7-fffd-434e-9276-a011fbb52d8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hermetic Plus™
• Version Model Number: INS8301
• Catalog Number: INS8301
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780023869 [Previous]
GS1	10381780537434 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-08
• Device Publish Date: 2024-06-28

Devices Manufactured by Integra Lifesciences Corporation

• 10381780537434 - Hermetic Plus™: 2024-07-08Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Sites
• 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