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)

Lumboperitoneal shunt spinal catheter

• Primary Device ID: 10381780034247
• NIH Device Record Key: a570bade-7b78-4023-b92e-355ead68a2a7
• Commercial Distribution Discontinuation: 2023-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Lumbar Catheter
• Version Model Number: 951103
• Catalog Number: 951103
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780034247 [Primary]
HIBCC	M2729511031 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944595

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-18
• Device Publish Date: 2015-10-01

Devices Manufactured by INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

• 10381780035602 - Integral Drainage Set: 2024-12-23 The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; small diameter drainage inlet tube w
• 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 Catheter: 2024-03-18The 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 Catheter: 2024-03-18 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 Reservoir: 2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
• 10381780034599 - CSF Reservoir: 2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
• 10381780034605 - CSF Reservoir: 2024-03-18 The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated c
• 10381780034612 - CSF Reservoir: 2024-03-18 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