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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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Paxos Scope - 00851434007017

DigiSIght Technologies Inc. Paxos Scope Ophthalmic Camera with optional 20D acrylic lens
DIGISIGHT TECHNOLOGIES, INC.
40807
In Commercial Distribution

  • 00851434007017 ()


  • Ophthalmic fundus camera

Paxos Scope - 00851434007000

DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
DIGISIGHT TECHNOLOGIES, INC.
40806
In Commercial Distribution

  • 00851434007000 ()


  • Ophthalmic fundus camera

Eli Ezer - 00851158007690

Non-mydriatic Auto Fundus Camera
U.S. OPHTHALMIC, L.L.C.
EFC-2600
In Commercial Distribution

  • 00851158007690 ()


  • Ophthalmic fundus camera

Spect Ophthalmic Camera - 00853501008002

The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera

identifeye Camera System, reconditioned - 00850067214281

The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera

identifeye Camera System - 00850067214274

The identifeye Camera System is a fundus ophthalmic camera.
Identifeye Health Inc.
850-30003-00
In Commercial Distribution

  • 00850067214274 ()


  • Ophthalmic fundus camera

identifeye Camera System, power supply - 00850067214236

identifeye Camera System power supply accessory
Identifeye Health Inc.
815-30020-00
In Commercial Distribution

  • 00850067214236 ()


  • Ophthalmic fundus camera

identifeye Camera System, tablet - 00850067214229

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

  • 00850067214229 ()


  • Ophthalmic fundus camera

Phoenix ICON GO - 00857253006088

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

Phoenix Clinical White Light Module - 00857253006064

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
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