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

• Primary Device ID: 10381780035596
• NIH Device Record Key: 85f80cc7-7720-4d4e-8522-17c6306e03ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraventricular Monitoring Catheter Set
• Version Model Number: 910130A
• Catalog Number: 910130A
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
• 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

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• 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	10381780035596 [Primary]
HIBCC	M272910130A1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K855058

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: 2021-07-22
• Device Publish Date: 2015-10-01

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