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

Ventriculo-peritoneal/atrial shunt valve
Primary Device ID10381780024408
NIH Device Record Keyec7f08ac-7a51-4292-94a8-642599fb900a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra Spetzler™ Lumbar Peritoneal Shunt System
Version Model NumberNL8507210
Catalog NumberNL8507210
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780024408 [Primary]
HIBCCM269NL85072101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-22
Device Publish Date2015-09-22

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

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

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