Duns Number:949114925
Device Description: The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for gener 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.
Catalog Number
-
Brand Name
Phoenix ICON GO
Version/Model Number
PCI 40-2001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PJZ
Product Code Name
Camera, Ophthalmic, General-Use
Public Device Record Key
b7d628b1-e9ce-4b9b-be7c-99502dac3f5e
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 21, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |