FDA.reportPublic FDA data

Drainage Accessory Kit

Primary DI
10381780034131
Brand
Drainage Accessory Kit
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
910122
Catalog number
910122
Device description
Drainage Accessory Kit: 500 ml Drainage Bag for intraoperative drainage of cerebrospinal fluid.
Published
2015-10-01
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780034135PackageGS15Not in Commercial Distribution
10381780034131PrimaryGS10
M2729101221SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178003413530381780034135
1038178003413110381780034131

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid external drainage kitA collection of sterile devices intended to be used with an intracerebral or spinal infusion/drainage catheter (not included) to collect drained cerebrospinal fluid (CSF) from the brain ventricles or from the lumbar subarachnoid (intrathecal) region as a means of reducing CSF volume and intracranial pressure (ICP). It typically includes devices such as a drip chamber, drainage bag, tubing set, catheter connector, stopcock, and filter. This is a single-use device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
531408342
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780250371Licox ®VK522016-08-04
10381780023715Integra®910110A910110A2015-10-01
10381780034117External Drainage Set9101092016-06-24
10381780034186Integral Drainage Set9104109104102015-10-01
10381780035541External Drainage Set910116A910116A2015-10-01
10381780035558External Drainage Set910116D910116D2015-10-01
10381780035602Integral Drainage Set910410B910410B2015-10-01
10381780034124Lumbar Catheter Accessory Kit9101219101212015-10-01
10381780034193Integral Drainage Set9104129104122015-10-01
10381780034209Integral Drainage Set9104209104202015-10-01
10381780035527External Drainage Set910112A910112A2015-10-01
10381780035565External Drainage Set910120A910120A2015-10-01
10381780035589External Drainage Set910123A910123A2015-10-01
10381780457305Contour-Flex Valve and Shunt System11811118112018-01-12
10381780457312Contour-Flex Valve and Shunt System11812118122018-01-12
10381780457329Contour-Flex Valve and Shunt System11813118132018-01-12
10381780457459Contour-Flex Valve and Shunt System14085140852018-01-12
10381780457466Contour-Flex Valve and Shunt System14086140862018-01-12
10381780457473Contour-Flex Valve and Shunt System14087140872018-01-12
10381780457541Contour-Flex Valve and Shunt SystemCFRHCFRH2018-01-12

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Primary DI, Brand, Company table
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10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
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10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
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