FDA.reportPublic FDA data

Integra LPV II Valve Shunt Kit

Primary DI
10381780072485
Brand
Integra LPV II Valve Shunt Kit
Company
Integra Lifesciences Corporation
Model
NL8509850
Catalog number
NL8509850
Device description
STANDARD LPV II SHUNT KIT, MED.The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, standard, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability.
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
K153041000
K974708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153041000Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation2016-03-14JXG
K974708000GEMINI STANDARD AND MINI VALVESNeurocare Group1998-03-10JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780072485PrimaryGS10
M269NL85098501SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007248510381780072485

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculoperitoneal shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the ventricles (fluid-filled cavities) of the brain to the peritoneal cavity, where it can be absorbed into the body. It typically consists of three main parts: 1) a ventricular catheter with holes which allow the CSF to drain through the catheter and to; 2) a mechanical ventriculoperitoneal (VP) shunt valve that typically opens at a pre-set pressure; and 3) a distal catheter that channels the CSF to the peritoneal cavity. This device is intended as a therapeutic measure for situations where increased CSF causes increased intracranial pressure (hydrocephalus).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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

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