Integra DP Valve System 9MA145W

GUDID 10381780035657

Integra DP Valve System is an implantable device which serves as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site (differential pressure valve). It provides controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt
Primary Device ID10381780035657
NIH Device Record Keyd30569ea-6c92-4318-84b1-bf901fc6633a
Commercial Distribution Discontinuation2017-04-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIntegra DP Valve System
Version Model Number9MA145W
Catalog Number9MA145W
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
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 Datetrue
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780035657 [Primary]
HIBCCM2729MA145W1 [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 Date2021-04-07
Device Publish Date2015-10-01

On-Brand Devices [Integra DP Valve System]

10381780035657Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033608Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033592Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033585Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033578Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033561Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033554Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033547Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033509Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033493Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033486Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033479Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033462Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033455Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033448Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033431Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033424Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033417Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033400Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033394Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033295Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033288Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033271Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033264Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033257Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033240Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033233Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033226Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033219Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033196Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033189Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033165Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
10381780033158Integra DP Valve System is an implantable device which serves as a parallel flow pathway to dive
M2729MD21021Fixed-in Subcutaneous Tube Passer for Valve Tunnelization.
M2729MD21011Subcutaneous Tube Passer for Valve Tunnelization.

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