FDA.reportPublic FDA data

Dual Outlet Convertible Integra™ Reservoir

Primary DI
10381780112273
Brand
Dual Outlet Convertible Integra™ Reservoir
Company
Integra Lifesciences Corporation
Model
NL79034S02
Catalog number
NL79034S02
Device description
The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or CSF. The Convertible model incorporates an outlet tube in addition to an inlet tube. The outlet tube may be connected to a distal catheter, allowing the reservoir to be used in a shunting system, if later indicated. The 2.5cm base diameter reservoir is a flat bottom design; the 1.5cm base diameter reservoir is a burr-hole model.
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
10381780112273PrimaryGS10
M269NL79034S021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011227310381780112273

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid reservoirA sterile, closed system designed to access the cerebral ventricles to drain and collect cerebrospinal fluid to reduce intracranial pressure (ICP). 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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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10381780541394Durepair®62106621062026-03-11
10381780540823Durepair®62110621102026-03-11
10381780541424Durepair®62158621582026-03-11
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05
10381780537182MAYFIELD®A4000A40002025-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000422646StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
00763000422684StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
03760409446294Phoenix NeuroSOPHYSAJXG2025-12-24
B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
10381780521051CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535386CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535409CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535416CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535423CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535904CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535966CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535980CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536000CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536024CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536048CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536062CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536086CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536109CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
B775EVAC0PHASORPHASOR HEALTH LLCJXG2025-06-04
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04041906506698XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
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