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Integra Pudenz Ventricular Catheter

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra Pudenz Ventricular Catheter FDA UDI
Generic Name
Intracerebral infusion/drainage catheter, long-term FDA UDI
Device Name
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. FDA UDI
Model / Reference
NL96001S01 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
NL96001S01 FDA UDI
Primary DI / UDI-DI
10381780071792 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Intracerebral infusion/drainage catheter, long-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intracerebral infusion/drainage catheter, long-term

Integra Pudenz Ventricular Catheter by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracerebral infusion/drainage catheter, long-term.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI 4a053d95-ee9d-42ab-a368-ab58fac14d4f 36 fields · synced May 30, 2026