Intraventricular Monitoring Catheter Set 910130A

GUDID 10381780035596

The Intraventricular Monitoring Catheter Set (IVMCS) contains: a 35 cm Radiopaque Ventricular Catheter with large holes and graphite length marks at 5, 10, 15 cm from the tip; a Catheter passer with barbed end; a F8 Luer lock connector; a 35 cm introducer; a 20 cm introducer; a Slit suture clamp; a Watertight cap; a T-Connector/Stopcock Assembly (male Luer lock T-Connector with self-sealing injection/sampling port, drainage tube, four-way stopcock with two female Luer Lock outlet connectors, and watertight cap).

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracerebral infusion/drainage catheter, short-term
Primary Device ID10381780035596
NIH Device Record Key85f80cc7-7720-4d4e-8522-17c6306e03ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntraventricular Monitoring Catheter Set
Version Model Number910130A
Catalog Number910130A
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
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780035596 [Primary]
HIBCCM272910130A1 [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 Date2021-07-22
Device Publish Date2015-10-01

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