FDA.reportPublic FDA data

Dornier MedTech

Primary DI
04049957004095
Brand
Dornier MedTech
Company
Dornier MedTech GmbH
Model
Genesis
Catalog number
K1034267
Device description
Genesis Urology Imaging System, Right, FPD, 65 KW, 480 V
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122768000GENESISDornier Medtech America, Inc.2013-01-18JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049957004095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049957004095040499570040954049957004095

GMDN Terms#

Term, Definition table
TermDefinition
Stationary uro-gynaecological fluoroscopic x-ray system, digitalA stationary diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. It uses digital techniques for real-time image capture, display and manipulation and include spot-film capabilities as well as fluoroscopic features. It is commonly used for imaging and x-ray guided surgical or interventional procedures. The images can be viewed in both real-time and delayed formats and may include various levels of imaging processing and analysis capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
388104085
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049958000218Dornier MedTechMedilas D LiteBeam+ (D-Plug)K20116272018-09-11
04049958000225Dornier MedTechMedilas D MultiBeam (D-Plug)K20116912018-09-11
04049958001307Dornier MedTechMedilas D FlexiPulse (D-Plug)K20117432018-09-11
04049958001383Dornier MedTechMedilas D MultiBeam (D-Plug)K20119152018-09-13
04049958002090Dornier MedTechMedilas D30 1064 (SMA)K20120152018-09-12
04049958002229Dornier MedTechMedilas D LiteBeam+ (1470 SMA)K20124012018-09-13
04049958002441Dornier MedTechMedilas D LiteBeam+ (1470 D-Plug)K20129572018-09-11
04049958001468Dornier MedTech600 Micron Disposable K10080842018-09-11
04049958001529Dornier MedTech600 Micron Disposable Nozzle TipK10012912018-09-11
04049958001536Dornier MedTech600 Micron Disposable Nozzle TipK10012922018-09-11
04049958001543Dornier MedTech600 Micron Disposable Nozzle TipK10012932018-09-11
04049958001673Dornier MedTech600 Micron Disposable BarefiberK10105002018-09-12
04049958001789Dornier MedTech400 Micron Disposable NA 0.37K20107102018-09-11
04049958001925Dornier MedTech600 Micron Disposable K20121462018-09-11
04049958002120Dornier MedTech400 Micron Disposable NA 0.37K20118222018-09-13
04049958002144Dornier MedTech600 Micron Disposable K20118242018-09-11
04049958004551Dornier ThulioK2016000K20160002023-01-27
04049958000065Dornier MedTech600 Micron Disposable Rinsing TubeK10012952018-09-11
04049958000171Dornier MedTechMedilas Fibertome 8100K20115002018-09-13
04049958001741Dornier MedTech400 Micron Disposable NA 0.22K20102912018-09-11

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