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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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ICG FILTER ATTACHMENT IF-1 for RETINAL CAMERA TRC-50DX - 04562123289893

No Description
TOPCON CORPORATION
IF-1
In Commercial Distribution

  • 04562123289893 ()


  • Ophthalmic fundus camera

TV RELAY LENS ADAPTER TL-211 for RETINAL CAMERA TRC-50DX - 04562123289848

No Description
TOPCON CORPORATION
TL-211
In Commercial Distribution

  • 04562123289848 ()


  • Ophthalmic fundus camera

Neolight - 00852788008071

White Light Module
NEOLIGHT LLC
PCI 40-1005
In Commercial Distribution

  • 00852788008071 ()


  • Ophthalmic fundus camera

Neolight - 00852788008064

ICON Footswitch
NEOLIGHT LLC
PCI 30-1000
In Commercial Distribution

  • 00852788008064 ()


  • Ophthalmic fundus camera

Neolight - 00852788008057

ICON GO Control Box
NEOLIGHT LLC
PCI 40-1030
In Commercial Distribution

  • 00852788008057 ()


  • Ophthalmic fundus camera

Neolight - 00852788008040

Diffuser
NEOLIGHT LLC
PCI 40-1017
In Commercial Distribution

  • 00852788008040 ()


  • Ophthalmic fundus camera

Neolight - 00852788008026

FA Module
NEOLIGHT LLC
PCI 40-1004
In Commercial Distribution

  • 00852788008026 ()


  • Ophthalmic fundus camera

Neolight - 00852788008019

ICON Cart Control Box
NEOLIGHT LLC
PCI 40-1003
In Commercial Distribution

  • 00852788008019 ()


  • Ophthalmic fundus camera

Phoenix Clinical ICON - 00857253006040

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 - 00857253006002

Phoenix Clinical ICON cart assembly.
Phoenix Clinical
PCI 40-1001
In Commercial Distribution

  • 00857253006002 ()
PCI 40-1001

  • Ophthalmic fundus camera
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