Portnoy Ventricular Catheter NL8501229

GUDID 10381780024279

CATHETER PORTNOY VENTRICULAR STRIPED The Portnoy Ventricular Catheter is designed for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This silicone elastomer catheter employs silicone elastomer flanges near the proximal tip to help reduce the possibility of obstruction of the drainage holes during insertion and resultant occlusion of the catheter. The Portnoy Ventricular Catheter has seven flanges. During insertion, these flanges tend to fold back in a closed-umbrella position to protect the drainage holes which are in the catheter tube between the flanges. A stripe, made of barium sulfate impregnated silicone elastomer, is embedded in the wall of the catheter. The catheter tip is made from a radiopaque, tantalum impregnated silicone elastomer. Black length markers are also located at 10 and 15cm from the tip to assist in determining the position of the catheter. This catheter is supplied with a stylet.

Integra Lifesciences Corporation

Intracerebral infusion/drainage catheter, long-term
Primary Device ID10381780024279
NIH Device Record Key9c3d60a2-f2c0-4f57-a40f-e63a243beef4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortnoy Ventricular Catheter
Version Model NumberNL8501229
Catalog NumberNL8501229
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0
Length18 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780024279 [Primary]
HIBCCM269NL85012291 [Secondary]

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-09-22
Device Publish Date2016-12-15

Devices Manufactured by Integra Lifesciences Corporation

10381780542254 - MAYFIELD®2026-02-13 MAYFIELD® Ghost™ Base Unit, Post
10381780542261 - MAYFIELD®2026-02-13 MAYFIELD® Ghost™ Base Unit, Post S&R
10381780537182 - MAYFIELD®2025-09-02 MAYFIELD® Ghost™ Base Unit, Post
M24841C14441 - MAYFIELD®2025-04-02 Left Horseshoe Gel Pad
M24841C14451 - MAYFIELD®2025-04-02 Right Horseshoe Gel Pad
M248A1008P1 - MAYFIELD®2025-04-02 POOL - MAYFIELD GENERAL PURPOSE HEADREST
M248A1011P1 - MAYFIELD®2025-04-02 POOL- MAYFIELD HORSESHOE HEADREST
M248A1011SRL1 - MAYFIELD®2025-04-02 MAYFIELD HORSESHOE HEADREST

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.