Ventricular Antechamber 999014

GUDID 10381780034483

The Integra Ventricular Antechamber is a radiopaque component of a Cerebrospinal Fluid (CSF) shunt. The Ventricular Antechamber Kit includes a Ventricular Antechamber, a separate Straight Ventricular Catheter, featuring radiopaque Length Markings, a Right Angle Guide and a Wire Introducer. Other configurations are available: Ventricular Antechamber alone; Ventricular Antechamber with an integrated Right Angle Ventricular Catheter (Integral Ventricular Reservoir).

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracerebral infusion/drainage catheter, long-term

• Primary Device ID: 10381780034483
• NIH Device Record Key: 712d30ad-17ae-4e43-ba1f-32a4d8435240
• Commercial Distribution Discontinuation: 2021-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ventricular Antechamber
• Version Model Number: 999014
• Catalog Number: 999014
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780034483 [Primary]
HIBCC	M2729990141 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955832

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: 2023-02-09
• Device Publish Date: 2015-10-01

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