Subdural Catheter 951310

GUDID 10381780034261

The Subdural Drainage Catheter is a radiopaque, silicone elastomer, drainage catheter consisting of a F8 tubing with a flattened, hollow cage at the distal tip. The Kit contains: 1 Subdural Catheter, 1 Introducing Rod, 1 Luer-lock Connector, 1 Right Angle Guide, 1 Butterfly Suture Clamp, 1 Subcutaneous Passer, 1 Disposable Drill Bit (5 mm) with adjustable stop and 1 Allen Wrench

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 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: 10381780034261
• NIH Device Record Key: 0767e9a9-8641-471e-8c2d-6ed9ff884e3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Subdural Catheter
• Version Model Number: 951310
• Catalog Number: 951310
• 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: false
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780034261 [Primary]
HIBCC	M2729513101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974726

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: 2022-10-25
• Device Publish Date: 2015-10-01

On-Brand Devices [Subdural Catheter]

• 10381780034278: The Subdural Drainage Catheter is a radiopaque, silicone elastomer, drainage catheter consisting
• 10381780034261: The Subdural Drainage Catheter is a radiopaque, silicone elastomer, drainage catheter consisting