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 Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term
Primary Device ID10381780034483
NIH Device Record Key712d30ad-17ae-4e43-ba1f-32a4d8435240
Commercial Distribution Discontinuation2021-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVentricular Antechamber
Version Model Number999014
Catalog Number999014
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780034483 [Primary]
HIBCCM2729990141 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-02-09
Device Publish Date2015-10-01

Devices Manufactured by INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

M2729105001 - Integra®2024-03-18 The Suction Reservoir Kit is designed to be used with the Subdural Drainage Catheter. The kit contains an extension line and a S
10381780034247 - Lumbar Catheter2024-03-18 The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing with two open-ended arms (75 mm each) fe
10381780034582 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
10381780034599 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
10381780034605 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
10381780034612 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
M27217185C121 - Integra®2024-03-18 The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG
M27217185C161 - Integra®2024-03-18 The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG

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