Integra Spetzler™ Lumbar Peritoneal Shunt System NL8507210

GUDID 10381780024408

SPETZLER LUMBAR PERITONEAL SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. The lumbar catheter is inserted into the lumbar subarachnoid space through a 8.89cm, 14-gauge Touhy spinal needle with a Huber tip. A catheter passer and peritoneal trocar may be used to bring the peritoneal catheter section around the flank and into the peritoneal cavity. The One-Piece Lumbar Peritoneal Shunt model is a single, barium impregnated silicone elastomer catheter, one end of which has the features of the proximal tip of the lumbar catheter, the other end of which has the features of the distal end of the peritoneal catheter. A flushing reservoir is not incorporated in the one-piece model. Three movable, separate suture collars are used to secure both ends and the center portion of the catheter to subcutaneous tissue at the lumbar, flank and abdominal incision sites. The proximal or lumbar end of the one-piece model catheter is open-ended and cut at an angle. Four black, tantalum impregnated, silicone elastomer length markers are placed on the lumbar end of the shunt. A separate stainless steel connector is supplied.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780024408
• NIH Device Record Key: ec7f08ac-7a51-4292-94a8-642599fb900a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Spetzler™ Lumbar Peritoneal Shunt System
• Version Model Number: NL8507210
• Catalog Number: NL8507210
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780024408 [Primary]
HIBCC	M269NL85072101 [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