Duns Number:338702316
Device Description: The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.
Catalog Number
APFLAOP100
Brand Name
EIDON
Version/Model Number
EIDON FA
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
K180526
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
8909ce1b-bd1a-4133-ad65-a4589cfd8922
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
July 23, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |