FDA.reportPublic FDA data

Atrial Catheter

Primary DI
10381780035817
Brand
Atrial Catheter
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
9MZ100
Catalog number
9MZ100
Device description
The Atrial Catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the right atrium of the heart. The distal end of the catheter does not have any slits.
Published
2015-10-01
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
K861377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861377000STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVESCordis Corp.1986-06-19JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780035817PrimaryGS10
M2729MZ1001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003581710381780035817

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal/atrial cerebrospinal fluid catheterA flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.

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
531408342
Device count
1
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
10381780034131Drainage Accessory Kit9101229101222015-10-01
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

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Primary DI, Brand, Company table
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