FDA.reportPublic FDA data

Integra Ventricular Catheter

Primary DI
10381780071204
Brand
Integra Ventricular Catheter
Company
Integra Lifesciences Corporation
Model
NL99023S01
Catalog number
NL99023S01
Device description
23 CM BARIUM IMPREG. VENTRICULAR CATHETER The Integra Ventricular Catheter is designed for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This catheter is supplied with a right angle guide. The catheter is fully impregnated with barium for improved radiopacity. The catheter has multiple perforations near the tip to facilitate drainage of CSF and to help reduce clogging of the catheter lumen. The extreme tip of the catheter is closed. The catheter incorporates markers at 1-centimeter intervals from 4 to 10 cm, with larger markers at 5cm and 10cm. A stylet is provided.
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780071204PrimaryGS10
M269NL99023S011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007120410381780071204

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, long-termA sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10381780540823Durepair®62110621102026-03-11
10381780541424Durepair®62158621582026-03-11
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10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05
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M24841C14441MAYFIELD®41C144441C14442018-04-13
M24841C14451MAYFIELD®41C144541C14452018-04-13
M248A1008P1MAYFIELD®A1008PA1008P2018-05-11
M248A1011P1MAYFIELD®A1011PA1011P2018-04-19
M248A1011SRL1MAYFIELD®A1011SRLA1011SRL2018-05-03
M248A1012P1MAYFIELD®A1012PA1012P2018-04-19
M248A1012SRL1MAYFIELD®A1012SRLA1012SRL2018-05-03
M248A1051P1MAYFIELD®A1051PA1051P2018-04-19
M248A1051SRL1MAYFIELD®A1051SRLA1051SRL2018-05-03
M248A1073P1MAYFIELD®A1073PA1073P2018-04-19
M248A1073SRL1MAYFIELD®A1073SRLA1073SRL2018-05-03
M248A1112P1MAYFIELD®A1112PA1112P2018-04-19
M248A1112SRL1MAYFIELD®A1112SRLA1112SRL2018-05-03

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Primary DI, Brand, Company table
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