FDA.reportPublic FDA data

Integra DP Valve System

Primary DI
10381780035732
Brand
Integra DP Valve System
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
9MD2102
Catalog number
9MD2102
Device description
Fixed-in Subcutaneous Tube Passer for Valve Tunnelization.
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

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
10381780035732PrimaryGS10
M2729MD21021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003573210381780035732

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780535362CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535379CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535881CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535928CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535942CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780537014CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537021CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537038CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537045CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537069CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537106CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537144CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537151CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537496Hermetic™Integra Lifesciences CorporationJXG2024-06-28
10381780538325CODMAN® VPV®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-06-28
10381780537489N/AIntegra Lifesciences CorporationJXG2024-06-21
10381780536734CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536741CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536758CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536765CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536789CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536819CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536840CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536864CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536901CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536949CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29