FDA.reportPublic FDA data

Brainlab Flexible Catheter

Primary DI
04056481006419
Brand
Brainlab Flexible Catheter
Company
Brainlab SE
Model
19773
Catalog number
19773
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K123605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123605000SMARTFLOW CATHETERMri Interventions, Inc.2013-08-16HCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481006419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481006419040564810064194056481006419

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49899915680contact@brainlab.com

Regulatory Flags#

DUNS number
314482980
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres M581932026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres ML581942026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres L581952026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1581962026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2581972026-10-29
04056481147693Quip Instrument Adapter Clamp Size S582102026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size M582112026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size L582122026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XL582132026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular Instruments582142026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical Instruments582152026-10-29
04056481147754Quip Instrument Adapter Extension 50 mm582162026-10-29
04056481147761Quip Instrument Adapter 45° Angled582172026-10-29
04056481145323Patient Reference Carbon-Clamp Spine & Trauma558232026-10-27
04056481148201Sterilization Tray Accessories Spine52306C2026-10-27
04056481148218Sterilization Tray Accessories Spine & Trauma52326A2026-10-27
04056481148225Sterilization Tray Accessories Spine MIS52313B2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMF52311A2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)52305A2026-10-27
04056481146207Spine Planning3.02026-10-23

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