N/A

GUDID 10381780211082

Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal fluid (CSF) from an intraventricular catheter to a collection bag. The system can be used for external drainage, and the management of hydrocephalic shunt infections, or treatment of other cerebral conditions such as pre-operative or post-operative pressure monitoring of CSF to control increased intracranial pressure.

Integra Lifesciences Corporation

Ventriculoperitoneal shunt
Primary Device ID10381780211082
NIH Device Record Key1a369e21-6544-4ca5-ae99-6ab0c952e701
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberNL850500V
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

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

Device Issuing AgencyDevice ID
GS110381780211082 [Primary]
GS110381780537489 [Primary]

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 Date2017-02-14

On-Brand Devices [N/A]

30381780490016creos™ xenoplug Absorbable Collagen Wound Dressing for Dental Surgery
30381780490023creos™ xenocote Absorbable Collagen Wound Dressing for Dental Surgery
30381780490030creos™ xenotape Absorbable Collagen Wound Dressing for Dental Surgery
10381780211082Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal
10381780071273Multi-Purpose Valve, Model: High Pressure 95-150mm H20 closing pressure

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