Duns Number:338702316
Device Description: The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.
Catalog Number
-
Brand Name
DRSplus
Version/Model Number
DRSplus
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
K192113
Product Code
MYC
Product Code Name
Ophthalmoscope, Laser, Scanning
Public Device Record Key
9d5fc72b-dbaa-4ad0-9e7f-9b1ea8eae888
Public Version Date
December 17, 2019
Public Version Number
1
DI Record Publish Date
December 09, 2019
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 |