FDA.reportPublic FDA data

DORADO

Primary DI
04260590370525
Brand
DORADO
Company
L A P GMBH LASER APPLIKATIONEN
Model
DORADOnova blue wall
Catalog number
0014640-0014
Published
2019-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260590370525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260590370525042605903705254260590370525

GMDN Terms#

Term, Definition table
TermDefinition
Laser patient positioning systemA fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313586582
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260590372352THALES 3D MR SCANNERThales Phantom 0,35T0016164-00012021-09-17
04260590372383THALES 3D SCANNERCarriage System Conv.0016165-00022021-09-17
04260590372680LUNA 3DLUNA Camera Pod0018365-00012024-07-26
04260590372604LUNA 3DLUNA Camera Pod00189142024-06-17
04260590372581LUNA 3DLUNA Distribution Box0018364-00082024-06-17
04260590372598LUNA 3DLUNA Distribution Box0018364-00092024-06-17
04260590372611LUNA 3DLUNA 3D Workstation Software00184382024-06-17
04260590372628LUNA 3DLUNA 3D Central Server Software00184402024-06-17
04260590372635LUNA 3DLUNA SGRT PC0018346-00022024-06-17
04260590372642LUNA 3DLUNA SGRT PC0018346-00032024-06-17
04260590372659LUNA 3DCentral Server host PC Luna 3D0018439-00012024-06-17
04260590372666LUNA 3DLUNA 3D Workstation Software00184382024-06-17
04260590372673LUNA 3DLUNA 3D Central Server Software00184402024-06-17
04260590370860EASY CUBEEASY CUBE Core Pack0014421-00012023-08-31
04260590370877EASY CUBEEASY CUBE Cylinder Pack S0014421-00022023-08-31
04260590370884EASY CUBEEASY CUBE Cylinder Pack F0014421-00032023-08-31
04260590370891EASY CUBEEASY CUBE Head/Oval Pack F0014421-00042023-08-31
04260590370907EASY CUBEEASY CUBE Body Pack S0014421-00052023-08-31
04260590370914EASY CUBEEASY CUBE Universal Pack0014421-00062023-08-31
04260590370921EASY CUBEEASY CUBE0014438-00012023-08-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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