Phoenix ICON GO

GUDID 00857253006088

Ophthalmic fundus camera

Primary Device ID	00857253006088
NIH Device Record Key	b7d628b1-e9ce-4b9b-be7c-99502dac3f5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Phoenix ICON GO
Version Model Number	PCI 40-2001
Company DUNS	949114925
Company Name	Phoenix Clinical
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00857253006088 [Primary]

PJZ	Camera, Ophthalmic, General-Use

Steralize Prior To Use	false
Device Is Sterile	false

00857253006057 - Phoenix ICON Cart System	2021-12-08 The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is inte
00857253006088 - Phoenix ICON GO	2021-03-01The 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.
00857253006088 - Phoenix ICON GO	2021-03-01 The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, co
00857253006002 - Phoenix Clinical ICON Cart	2018-03-29 Phoenix Clinical ICON cart assembly.
00857253006026 - Phoenix Clinical ICON Control Box	2018-03-29 Phoenix Clinical ICON Control Box
00857253006040 - Phoenix Clinical ICON	2018-03-29 The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is capture
00857253006064 - Phoenix Clinical White Light Module	2018-03-29 White light module for the Phoenix Clinical ICON retinal imaging system.