FDA.reportPublic FDA data

Dornier MedTech

Primary DI
04049957000714
Brand
Dornier MedTech
Company
Dornier MedTech GmbH
Model
Relax+
Catalog number
K1018869
Device description
Relax+ Mobile Examination Table
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
KQSTable, Cystometric, Non-Electric And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQSTable, Cystometric, Non-Electric And AccessoriesGastroenterology, Urology1

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
04049957000714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049957000714040499570007144049957000714

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose diagnostic imaging tableAn electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.

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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Primary DI, Brand, Company table
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