CSF Reservoir 999303

GUDID 10381780034605

The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated connector. The CSF Reservoir can be provided alone. Other configurations include a right angle ventricular catheter (7 cm or 9 cm length) and a 15 cm introducing rod, or a 15 cm straight ventricular catheter and a right angle guide. The ventricular catheter features radiopaque length markings at 2, 4, 6, 8, 10 cm from the tip.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term

• Primary Device ID: 10381780034605
• NIH Device Record Key: 8de30f99-db93-4907-8f05-d868432bba1a
• Commercial Distribution Discontinuation: 2023-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CSF Reservoir
• Version Model Number: 999303
• Catalog Number: 999303
• 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	10381780034605 [Primary]
HIBCC	M2729993031 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950315

FDA Product Code

• LKG: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

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

On-Brand Devices [CSF Reservoir]

• 10381780034612: The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene nee
• 10381780034605: The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene nee
• 10381780034599: The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene nee
• 10381780034582: The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene nee