FDA.reportPublic FDA data

Integra Spetzler™ Lumbar Peritoneal Shunt System

Primary DI
10381780072539
Brand
Integra Spetzler™ Lumbar Peritoneal Shunt System
Company
Integra Lifesciences Corporation
Model
NL97105S01
Catalog number
NL97105S01
Device description
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.
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101381000
K161992000
K811288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101381000HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMSIntegra LifeSciences Corporation2011-07-07JXG
K161992000Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation2016-09-22JXG
K811288000SPETZLER LUMBAR-PERITONEAL SYSTEMAmerican Heyer Schulte1981-06-26JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780072539PrimaryGS10
M269NL97105S011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007253910381780072539

GMDN Terms#

Term, Definition table
TermDefinition
Lumboperitoneal shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity, where it can be absorbed into the body, as a treatment for elevated intracranial pressure due to increased CSF. It typically consists of fully-implanted interconnected components that include a spinal catheter implanted into the subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a reservoir which can be punctured for sampling/infusion; and a peritoneal catheter implanted into the peritoneal cavity. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
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03760409441251SophysaSOPHYSAJXG2026-06-05
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