Integral Ventricular Reservoir

Basic Information

• Brand Name: Integral Ventricular Reservoir
• Primary DI: 10381780034513
• Version / Model: 999017
• Catalog Number: 999017
• 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: 2018-07-13
• Public Version Status: Update
• Public Device Record Key: badbf107-7d35-4a3c-8ce6-67c4667e9263
• Distribution End Date: 2018-07-03

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 Safe
• 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	10381780034513	GS1
Secondary	M2729990171	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, Vent. Cath. 7cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)