Integra Spetzler™ Lumbar Peritoneal Shunt System NL97105S01

GUDID 10381780072539

LONG SPETZLER 105CM LP SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. A variety of devices are available: a one-piece model without a reservoir; separate large or small reservoirs that contain a one-way valve, which may be used when a flushing capability is required; and a separate miter valve, available in low, medium, or high pressure, which may be used when added resistance is desired.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780072539
• NIH Device Record Key: 755bbac4-2b50-49c9-a208-66a797c3cb7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Spetzler™ Lumbar Peritoneal Shunt System
• Version Model Number: NL97105S01
• Catalog Number: NL97105S01
• 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: true
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780072539 [Primary]
HIBCC	M269NL97105S011 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101381

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

On-Brand Devices [Integra Spetzler™ Lumbar Peritoneal Shunt System]

• 10381780072539: LONG SPETZLER 105CM LP SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shunt
• 10381780072195: TUOHY NEEDLE 14g 6" for Lumbar Peritoneal Shunt A 6-inch, 14-gauge Tuohy needle used for insert
• 10381780071631: SPETZLER RESERVOIR The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospina
• 10381780071624: IN-LINE VALVE ASSEMBLY HIGH The Spetzler Lumbar Peritoneal Shunt System is designed to shunt ce
• 10381780071617: IN-LINE VALVE ASSEMBLY MED The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cer
• 10381780024422: SPETZLER RESERVOIR The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospina
• 10381780024415: IN-LINE VALVE ASSEMBLY LOW The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cer
• 10381780024408: SPETZLER LUMBAR PERITONEAL SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shun