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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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DRSplus - 08053677040116

The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.
CENTERVUE SPA
DRSplus
In Commercial Distribution

  • 08053677040116 ()


  • Ophthalmic fundus camera

DRS - 08053677040017

FUNDUS CAMERA
CENTERVUE SPA
DRS
In Commercial Distribution

  • 08053677040017 ()


  • Ophthalmic fundus camera

Buxton BioMedical - B7687211010

Penfield 1 Cup/Dissector
Buxton Biomedical Inc
72-1101
In Commercial Distribution

  • B7687211010 ()
72-1101

  • Telemetric sphygmomanometer

PROTOZ - B667PROTOZ1

ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667PROTOZ01 ()
  • B667PROTOZ1 ()


  • Ophthalmic fundus camera

NEXY - B667NEXY1

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667NEXY01 ()
  • B667NEXY1 ()


  • Ophthalmic fundus camera

Eyer 2 Basic - 07908616100097

Eyer 2 Basic
PHELCOM TECHNOLOGIES SA
Eyer 2 Basic
In Commercial Distribution

  • 07908616100097 ()


  • Ophthalmic fundus camera

Eyer - 07908616100042

Eyer Retinal Camera M-STD
PHELCOM TECHNOLOGIES SA
Eyer M-STD
In Commercial Distribution

  • 07908616100042 ()
M-STD

  • Ophthalmic fundus camera

Eyer - 07908616100011

Eyer Retinal Camera NM-STD
PHELCOM TECHNOLOGIES SA
Eyer NM-STD
In Commercial Distribution

  • 07908616100011 ()
NM-STD

  • Ophthalmic fundus camera

RetCam Portable - 00899281002137

The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam Portable
Not in Commercial Distribution

  • 00899281002137 ()


  • Ophthalmic fundus camera

RetCam Shuttle - 00899281002120

The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam Shuttle
Not in Commercial Distribution

  • 00899281002120 ()


  • Ophthalmic fundus camera
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