Ventricular Antechamber

Basic Information

• Brand Name: Ventricular Antechamber
• Primary DI: 10381780034483
• Version / Model: 999014
• Catalog Number: 999014
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 4
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 712d30ad-17ae-4e43-ba1f-32a4d8435240
• Distribution End Date: 2021-12-31

Device Description

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).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780034483	GS1
Secondary	M2729990141	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K955832	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Vent. Antechamber 0.3ml Internal Volume, Right Angle Guide 4.9mm Diam., Straight Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)