Duns Number:537208717
Device Description: The Riester ophthalmoscope has been designed for the examination of the eye and its backgr The Riester ophthalmoscope has been designed for the examination of the eye and its background.
Catalog Number
2020
Brand Name
uni® II May-ophthalmoscope XL 2.5 V
Version/Model Number
2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K925756
Product Code
HLJ
Product Code Name
Ophthalmoscope, Battery-Powered
Public Device Record Key
adc9e48e-5d40-45b4-a8e8-050d7c158138
Public Version Date
May 10, 2021
Public Version Number
3
DI Record Publish Date
January 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |