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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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KOWA VX-10a - 04987646804147

KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L48BK
In Commercial Distribution

  • 04987646804147 ()

  • Height: 620 Millimeter
  • Depth: 520 Millimeter
  • Width: 400 Millimeter
  • Weight: 35.5 Kilogram


  • Ophthalmic fundus camera

KOWA GENESIS-D - 04987646803973

The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
KOWA COMPANY,LTD.
K9L51K
In Commercial Distribution

  • 04987646803973 ()

  • Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
  • Camera unit Weight: 1070 Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm


  • Ophthalmic fundus camera

KOWA VX-10 - 04987646802006

KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L48K
In Commercial Distribution

  • 04987646802006 ()

  • Height: 620 Millimeter
  • Depth: 520 Millimeter
  • Width: 400 Millimeter
  • Weight: 39 Kilogram


  • Ophthalmic fundus camera

KOWA nonmyd a-DIII - 04987646800606

KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.
KOWA COMPANY,LTD.
K9L58K
In Commercial Distribution

  • 04987646800606 ()

  • Height: 462 Millimeter
  • Depth: 505 Millimeter
  • Width: 310 Millimeter
  • Weight: 22 Kilogram


  • Ophthalmic fundus camera

KOWA GENESIS-Df - 04987646800583

KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
KOWA COMPANY,LTD.
K9L51BK
In Commercial Distribution

  • 04987646800583 ()

  • Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
  • Camera unit Weight: 1070Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm


  • Ophthalmic fundus camera

DIGITAL MEDICAL SCOPE - 04987669101087

NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. DS-20 consists of control unit and optical lens DS-20F (Digital Eye Fundus Camera).
NIDEK CO.,LTD.
DS-20 Control Unit
In Commercial Distribution

  • 04987669101087 ()


  • Ophthalmic fundus camera

DIGITAL MEDICAL SCOPE - 04987669101001

NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-20F
In Commercial Distribution

  • 04987669101001 ()


  • Ophthalmic fundus camera

DIGITAL MEDICAL SCOPE - 04987669100998

NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-10F
In Commercial Distribution

  • 04987669100998 ()


  • Ophthalmic fundus camera

Vitazi View™ - 04719876420398

Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
VitaziView
In Commercial Distribution

  • 04719876420398 ()
700-C2701-431

  • Ophthalmic fundus camera

Halo - 04719876420275

Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
Halo
In Commercial Distribution

  • 04719876420275 ()
700-C2701-131

  • Ophthalmic fundus camera

NFC-600 - 04719876420268

Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-600
In Commercial Distribution

  • 04719876420268 ()
700-C2701-031

  • Ophthalmic fundus camera

Polaris - 04719876420176

Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
Polaris
In Commercial Distribution

  • 04719876420176 ()
700-C1101-431

  • Ophthalmic fundus camera

RetinaStation - 04719876420060

Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
RetinaStation
In Commercial Distribution

  • 04719876420060 ()
700-C1101-231

  • Ophthalmic fundus camera

NFC-700 - 04719876420053

Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-700
In Commercial Distribution

  • 04719876420053 ()
700-C1101-031

  • Ophthalmic fundus camera

Welch Allyn - 04719872711162

Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711162 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711155

Eye Fundus Camera: RetinaVue 700 Imager (RV700TUD-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711155 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711148

Eye Fundus Camera: RetinaVue 700 Imager (RV700TU-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711148 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711131

Eye Fundus Camera: RetinaVue 700 Imager (RV700B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711131 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711124

Eye Fundus Camera: RetinaVue 100 Imager (RV100PRO-C)
MEDIMAGING INTEGRATED SOLUTION INC.
1007
In Commercial Distribution

  • 04719872711124 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711117

Eye Fundus Camera: RetinaVue 100 Imager (RV100PROC)
MEDIMAGING INTEGRATED SOLUTION INC.
1007
In Commercial Distribution

  • 04719872711117 ()


  • Ophthalmic fundus camera
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