MoniTorr ICP™ Drainage Bag with Anti-Reflux Valve 10210

GUDID 10381780070900

500 ml replacement drainage bag with anti-reflux valve and drain tube for the MoniTorr ICP™ External CSF Drainage and Monitoring System.

Integra Lifesciences Corporation

Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit
Primary Device ID10381780070900
NIH Device Record Key8191567e-2075-43cb-9654-c32bb0e0e212
Commercial Distribution StatusIn Commercial Distribution
Brand NameMoniTorr ICP™ Drainage Bag with Anti-Reflux Valve
Version Model Number10210
Catalog Number10210
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 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 Latextrue
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
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 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
GS110381780070900 [Primary]
HIBCCM269102101 [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.