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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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identifeye Camera System tablet accessory
Identifeye Health Inc.
815-30023-01
In Commercial Distribution

  • 00850067214229 ()


  • Ophthalmic fundus camera
The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye.
Phoenix Clinical
PCI 40-2001
In Commercial Distribution

  • 00857253006088 ()


  • Ophthalmic fundus camera
White light module for the Phoenix Clinical ICON retinal imaging system.
Phoenix Clinical
PCI 40-1005
In Commercial Distribution

  • 00857253006064 ()
  • 00857253006095 ()
  • 00857253006125 ()
PCI 40-1005

  • Ophthalmic fundus camera
The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information.
Phoenix Clinical
PJZ
In Commercial Distribution

  • 00857253006040 ()
PCI-40-1000-P

  • Ophthalmic fundus camera
Phoenix Clinical ICON cart assembly.
Phoenix Clinical
PCI 40-1001
In Commercial Distribution

  • 00857253006002 ()
PCI 40-1001

  • Ophthalmic fundus camera
The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
Phoenix Clinical
PCI 40-1000
In Commercial Distribution

  • 00857253006057 ()


  • Ophthalmic fundus camera
Phoenix Clinical ICON Control Box
Phoenix Clinical
PCI 40-1003
In Commercial Distribution

  • 00857253006026 ()
PCI 40-1003

  • Ophthalmic fundus camera
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564052 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564038 ()


  • Cognitive assessment software
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