FDA.reportPublic FDA data

Innervision

Primary DI
00643169498082
Brand
Innervision
Company
MEDTRONIC PS MEDICAL, INC.
Model
27623
Device description
CATH 27623 INNERV15CM XTRA HOLES 2CM
Published
2015-07-10
Public version status
Update
Distribution status
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
HCACATHETER, VENTRICULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCACatheter, VentricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983331000MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102Medtronic PS Medical1998-12-16HCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169498082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169498082006431694980826431694980820643169498082

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
089055867
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13
00673978226835NA8591-602015-11-25
00643169497955Clear-Site®469182015-09-16
00613994450661Clear-Site®469182015-07-16
00763000422660StrataMR II46956MR2025-05-02
00763000422653Valve, StrataMR II, Regular46965MR2025-01-23
00763000422677Snap Shunt Assembly, StrataMR II, Regular46966MR2025-01-23
00763000422691Unassembled Shunt Kit, StrataMR II, Regular46967MR2025-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535805CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535843CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780536970CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780536987CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780536994CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537007CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537014CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537021CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537038CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537045CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537052CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537069CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537076CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537083CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537106CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537113CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537120CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537137CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537144CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537151CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
00763000028961Innervision, BioGlide®MEDTRONIC PS MEDICAL, INC.HCA2020-08-21
00763000333614Exacta™MEDTRONIC PS MEDICAL, INC.HCA2020-06-08
10381780521136CODMAN CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2020-06-03
10381780526803CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2020-05-11
10381780511540CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2020-04-01