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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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MSPT v3.0 - 00195893702190

No Description
Qr8 Health Inc
MSPT-30
Not in Commercial Distribution

  • 00195893702190 ()


  • Cognitive assessment software

MSPT Web v3.0 - 00195893329458

No Description
Qr8 Health Inc
MSPT-W30
Not in Commercial Distribution

  • 00195893329458 ()


  • Cognitive assessment software

CLARUS - 04057748096051

The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS Review Software can be installed on a separate review station (PC or laptop) for data review and analysis.
Carl Zeiss Meditec, Inc.
CLARUS Review Software
In Commercial Distribution

  • 04057748096051 ()


  • Ophthalmic fundus camera

CLARUS - 04057748096044

The CLARUS 700 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye.The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
Carl Zeiss Meditec, Inc.
700
In Commercial Distribution

  • 04057748096044 ()


  • Ophthalmic fundus camera

CLARUS - 04057748096037

The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.
Carl Zeiss Meditec, Inc.
500
In Commercial Distribution

  • 04057748096037 ()


  • Ophthalmic fundus camera

Verily Retinal Camera - 10860000249543

The Verily Retinal Camera is an ophthalmic camera used to acquire and transmit digital images of the human eye, including the retina. It is a prescription-use only medical device.
VERILY LIFE SCIENCES LLC
VRC-100
In Commercial Distribution

  • 10860000249543 ()


  • Ophthalmic fundus camera

Neolight - 10852788008085

ICON Handpiece
NEOLIGHT LLC
PCI 40-1002
In Commercial Distribution

  • 10852788008085 ()


  • Ophthalmic fundus camera

Millennium - 00190776166533

DESMARRES LID RETR
Avalign Technologies, Inc.
1-350152
In Commercial Distribution

  • 00190776166533 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166526

DESMARRES LID RETR
Avalign Technologies, Inc.
1-350151
In Commercial Distribution

  • 00190776166526 ()


  • Telemetric sphygmomanometer

Millennium - 00190776166519

DESMARRES LID RETR
Avalign Technologies, Inc.
1-350150
In Commercial Distribution

  • 00190776166519 ()


  • Telemetric sphygmomanometer
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