FDA.reportPublic FDA data

Integra Essential Shunt Kit Flat Bottom Design

Primary DI
10381780071600
Brand
Integra Essential Shunt Kit Flat Bottom Design
Company
Integra Lifesciences Corporation
Model
NL8504121
Catalog number
NL8504121
Device description
The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included.
Published
2015-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
K973525000

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
K973525000MAURICE WORLDWIDE SHUNT SYSTEMIntegra Neurocare, LLC1997-12-16JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780071600PreviousGS10
10381780356158PrimaryGS10
M269NL85041211SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007160010381780071600
1038178035615810381780356158

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
No natural rubber latex
true

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