Duns Number:650711448
Device Description: Remidio FOP application along with FOP NM-10 hardware is intended for use in capturing & s Remidio FOP application along with FOP NM-10 hardware is intended for use in capturing & storing images of the retina and surrounding area of eye, with or without the use of Mydriatic agent and presenting the data to clinicians for evaluation or diagnosis. Light from the device is shown into the patient eye & the camera of a smartphone is used to capture images of the eye.
Catalog Number
-
Brand Name
Remidio
Version/Model Number
Remidio FOP
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"
Yes
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
b48b402d-452a-4e41-8214-1abf31c63a07
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 2022
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 |