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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ILUMIEN™ - 00183739000630

Imaging System
LIGHTLAB IMAGING, INC.
900-700-00
In Commercial Distribution

  • 00183739000630 ()
900-700-00

  • Coronary optical coherence tomography system

BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL - 08056446900956

Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B8830073320
In Commercial Distribution

  • 08056446900956 ()


  • Electroencephalographic ambulatory recorder

BE Micro 21 CH MONO PLUG-IN HEADBOX - 08056446900949

Patient-interface for EEG ambulatory recorder
EB NEURO SPA
B8830073310
In Commercial Distribution

  • 08056446900949 ()


  • Electroencephalographic ambulatory recorder

EIDON - 08053677040093

The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.
CENTERVUE SPA
EIDON FA
In Commercial Distribution

  • 08053677040093 ()
APFLAOP100

  • Scanning-laser retinal imaging system

EIDON - 08053677040079

EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal infrared reflectance images, confocal visible reflectance images of the retina and fluorescence images of the retina, without pharmacological dilation. EIDON is a standalone device.
CENTERVUE SPA
EIDON AF
In Commercial Distribution

  • 08053677040079 ()
AIFLUME001

  • Scanning-laser retinal imaging system

EIDON - 08053677040062

RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluorescence images of the retina.
CENTERVUE SPA
RETIA
In Commercial Distribution

  • 08053677040062 ()
AINEUME001

  • Scanning-laser retinal imaging system

EIDON - 08053677040031

EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina, without pharmacological dilation. EIDON is a standalone device.
CENTERVUE SPA
EIDON
In Commercial Distribution

  • 08053677040031 ()
AMFUNME01

  • Scanning-laser retinal imaging system

MIR - 08052990322206

Portable spirometer for lung function testing
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank II Light
In Commercial Distribution

  • 08052990322206 ()


  • Expiratory peak flow meter, digital

MIR - 08052990322190

Portable spirometer for lung function testing
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank II PLUS
In Commercial Distribution

  • 08052990322190 ()


  • Expiratory peak flow meter, digital

MIR - 08052990322084

Portable spirometer for lung function testing with oximetry function
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank II PLUS
In Commercial Distribution

  • 08052990322084 ()


  • Expiratory peak flow meter, digital
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