Integra® NL97005S01

GUDID 10381780024460

5 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide continuous drainage of fluid from within a spinal cord cyst to a site outside the spinal canal. The T-tube diameter is small to minimize the size of the myelotomy and the catheter is flexible to minimize the spinal cord manipulation necessary to insert the tube into a spinal cord cyst. The T-shape allows drainage above and below the myelotomy site, helps prevent kinking by providing a right-angle exit through the dura, and reduces the risk of migration out of the spinal cord. The multi-holed catheter reduces the risk of clogging at the spinal end of the system. The suture tab allows the T-tube to be anchored to the dura or paraspinous muscles without the risk of shunt occlusion associated with a circumferential ligature. If a step down connector is used, it adapts the T-tube diameter to the peritoneal reflux control catheter.

Integra Lifesciences Corporation

Lumboperitoneal shunt

• Primary Device ID: 10381780024460
• NIH Device Record Key: a1f09244-4a8f-4898-a2ba-73b836b9b51f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: NL97005S01
• Catalog Number: NL97005S01
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780024460 [Primary]
HIBCC	M269NL97005S011 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854049

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: 2020-08-28
• Device Publish Date: 2015-09-22

On-Brand Devices [Integra®]

• 10381780072522: 3 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide cont
• 10381780024460: 5 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide cont
• M248440C10121: Right Horseshoe Gel Pad and Base Assembly
• M248440C10111: Left Horseshoe Gel Pad and Base Assembly
• 10381780344766: Integra® 16.5" BRS RETRACTOR ARM
• 10381780252498: Integra® Hardware Kit for UCHR
• 10381780537519: Integra® External Drainage System
• 10381780537502: Integra® External Drainage System