TraumaCath Ventricular Catheter Set NL8508420

GUDID 10381780072409

TRAUMACATH VENTRICULAR CATHETER SET The TraumaCath Ventricular Catheter set catheter is barium striped. Designed for diverting fluid from the ventricles through a series of drainage holes, the catheter can be inserted into the ventricular cavity with the stainless steel stylet. A trocar is supplied with the catheter to facilitate subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the suture tab. The luer lock supplied with each ventricular catheter set will connect the catheter to any Integra external drainage system.

Integra Lifesciences Corporation

Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term
Primary Device ID10381780072409
NIH Device Record Keye4e77719-875d-41a1-86fc-f49f5a095bf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTraumaCath Ventricular Catheter Set
Version Model NumberNL8508420
Catalog NumberNL8508420
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
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
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 Identifiers

Device Issuing AgencyDevice ID
GS110381780072409 [Primary]
HIBCCM269NL85084201 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2020-09-22
Device Publish Date2015-09-22

Devices Manufactured by Integra Lifesciences Corporation

M268WRISTFUSESET0 - Integra® Total Wrist Fusion System2024-04-05 The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nin
M248437A2224SRL1 - MAYFIELD®2024-04-05 MAYFIELD® XR2 Extension Arm Assembly
M2483138R1 - Omni-Tract®2024-04-05 Deaver Fixed Retractor, 2.75in x 4.5in (7.0cm x 11.4cm)
M2483086P1 - Omni-Tract®2024-04-05 Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
M2483145P1 - Omni-Tract®2024-04-05 Kelly Mod Retractor, 3in x 3in (7.6cm x 7.6cm) Fixed
M2483223P1 - Omni-Tract®2024-04-05 Fence Swivel Blade with 3/8in (1.0cm) Hole, 4in x 5in (10.2cm x 12.7cm)
M268S438A1200B1 - BUDDE®2024-04-05 SAMY™ Vascular Retractor Blade – Long 4.6"
M268S443A1012A1 - BUDDE®2024-04-05 BUDDE® Halo 12 inch (300 mm) Flex Arm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.