FDA.reportPublic FDA data

Dornier MedTech

Primary DI
04049957000578
Brand
Dornier MedTech
Company
Dornier MedTech GmbH
Model
UIMS
Catalog number
K1029226
Device description
UIMS Viewing Station SC High Line
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
NSXSoftware, Transmission And Storage, Patient Data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSXSoftware, Transmission And Storage, Patient Data

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840008069

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840008069DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)Dornier Medtech America, Inc.1984-12-19LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049957000578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049957000578040499570005784049957000578

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system operation softwareMainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a general-purpose x-ray system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used identify different operating system versions.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18033737712341THD Procto Software SystemTHD SPANSX2022-10-07
58051887042642THD Procto Software SystemTHD SPANSX2022-10-07
08033737713037THD Procto Software SystemTHD SPANSX2021-07-19
18033737712389THD Procto Software SystemTHD SPANSX2021-07-19
00852132007286PatientCare PlatformPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00852132007293BodyGuardian ConnectPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00852132007309ECG Plug-InPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00851831007078Picis Perioperative and Critical CarePicis Clinical Solutions, Inc.NSX2021-03-18
00851831007054Picis Perioperative and Critical Care Picis Clinical Solutions, Inc.NSX2019-11-06
00884838084674IntelliSpace ConsolePhilips Medical Systems HsgNSX2019-03-06
10884521762633Vital SyncCovidien LPNSX2018-09-26
10884521762626Vital SyncCovidien LPNSX2018-09-20
04049957000554Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04049957000561Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04012030013376seca analytics 115seca GmbH & Co. KGNSX2018-08-15
04012030013383seca analytics 115seca GmbH & Co. KGNSX2018-08-15
04012030013406seca analytics 115seca GmbH & Co. KGNSX2018-08-15
06944413808157NAEdan Instruments, Inc.NSX2017-11-27
00847946019976ChargerZoll Medical CorporationNSX2017-09-06
00884838059313IntelliVue XDS SoftwarePhilips Medizin Systeme Böblingen GmbHNSX2017-08-25
00851831007009Picis Perioperative and Critical CarePicis Clinical Solutions, Inc.NSX2017-04-14
00847946021887ZOLL Code Writer Zoll Medical CorporationNSX2017-03-17
00847946021894ZOLL Code Writer Zoll Medical CorporationNSX2017-03-17
00847946021900RescueNet ePCRZoll Medical CorporationNSX2017-03-17
00847946021917RescueNet ePCRZoll Medical CorporationNSX2017-03-17
00847946021924ZOLL ePCR iOSZoll Medical CorporationNSX2017-03-17
00847946021931ZOLL RescueNet LinkZoll Medical CorporationNSX2017-03-17
00847946021948ZOLL RescueNet LinkZoll Medical CorporationNSX2017-03-17
06944413808126NAEdan Instruments, Inc.NSX2016-12-03
06944413808140NAEdan Instruments, Inc.NSX2016-12-03