Intraventricular Monitoring Catheter Set

Basic Information

• Brand Name: Intraventricular Monitoring Catheter Set
• Primary DI: 10381780035596
• Version / Model: 910130A
• Catalog Number: 910130A
• 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: 5
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 85f80cc7-7720-4d4e-8522-17c6306e03ef
• Distribution End Date: 2021-12-31

Device Description

The Intraventricular Monitoring Catheter Set (IVMCS) contains: a 35 cm Radiopaque Ventricular Catheter with large holes and graphite length marks at 5, 10, 15 cm from the tip; a Catheter passer with barbed end; a F8 Luer lock connector; a 35 cm introducer; a 20 cm introducer; a Slit suture clamp; a Watertight cap; a T-Connector/Stopcock Assembly (male Luer lock T-Connector with self-sealing injection/sampling port, drainage tube, four-way stopcock with two female Luer Lock outlet connectors, and watertight cap).

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: Labeling does not contain MRI Safety Information
• 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
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-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 may also be intended for measurement of intracranial pressure (ICP). 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, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780035596	GS1
Secondary	M272910130A1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K855058	000
K914995	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Vent. Cath. 35cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducers 22cm and 37cm Length