Integra Pudenz Ventricular Catheter

Basic Information

• Brand Name: Integra Pudenz Ventricular Catheter
• Primary DI: 10381780071792
• Version / Model: NL96001S01
• Catalog Number: NL96001S01
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 4
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 4a053d95-ee9d-42ab-a368-ab58fac14d4f

Device Description

STRIPED PUD. VENTRICULAR CATHETER The Integra Pudenz Ventricular Cather is designed for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The Large Hole Model is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate-impregnated silicone elastomer, is imbedded in the wall of the catheter. The stripe provides a catheter which is radiopaque throughout its entire length, while keeping barium sulfate away from the surface of the catheter and allowing visual observation of flow through the catheter during implantation. The catheter has four pairs of holes near the tip to facilitate drainage of CSF and to help reduce clogging of the catheter lumen. The extreme tip of the catheter is closed. The catheter incorporates markers at 5, 6, 7, 10 and 15 cm. A stylet is provided, along with a right-angle guide.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• 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	10381780071792	GS1
Secondary	M269NL96001S011	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Tubing: 1.3mm ID x 2.5mm OD; Total Length: 20cm (8") (all dimensions nominal)