Lumbar Catheter 951103

GUDID 10381780034247

The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing with two open-ended arms (75 mm each) featuring several rows of inlet holes. The Y-shape consists of a 30 degree angle connection between the arms and the drainage catheter. The catheter overall length is 80 cm. A F5 radiopaque silicone Suture Clamp and a F8 -F5 radiopaque polypropylene Stepdown Connector (OD: 1.8 and 1.5 mm; ID: 0.8 mm) are supplied with the catheter.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

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Primary Device ID10381780034247
NIH Device Record Keya570bade-7b78-4023-b92e-355ead68a2a7
Commercial Distribution Discontinuation2023-12-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLumbar Catheter
Version Model Number951103
Catalog Number951103
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780034247 [Primary]
HIBCCM2729511031 [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 Date2024-03-18
Device Publish Date2015-10-01

Devices Manufactured by INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

M2729105001 - Integra®2024-03-18 The Suction Reservoir Kit is designed to be used with the Subdural Drainage Catheter. The kit contains an extension line and a S
10381780034247 - Lumbar Catheter2024-03-18The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing with two open-ended arms (75 mm each) featuring several rows of inlet holes. The Y-shape consists of a 30 degree angle connection between the arms and the drainage catheter. The catheter overall length is 80 cm. A F5 radiopaque silicone Suture Clamp and a F8 -F5 radiopaque polypropylene Stepdown Connector (OD: 1.8 and 1.5 mm; ID: 0.8 mm) are supplied with the catheter.
10381780034247 - Lumbar Catheter2024-03-18 The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing with two open-ended arms (75 mm each) fe
10381780034582 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
10381780034599 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
10381780034605 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
10381780034612 - CSF Reservoir2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
M27217185C121 - Integra®2024-03-18 The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG
M27217185C161 - Integra®2024-03-18 The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG
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