Duns Number:650711448
Device Description: Remidio Microscope Recording device MRD-10 is a device attached to a surgical microscope & Remidio Microscope Recording device MRD-10 is a device attached to a surgical microscope & is used for the video recording of the surgeries related to the eye with an inherent simplicity built in its operation & use.MRD-10 device enables 4k resolution and 60FPS recording using high-resolution optics & i Phone.
Catalog Number
650711448
Brand Name
Remidio
Version/Model Number
MRD-10
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)
Yes
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
2c9ffbd2-201b-46c4-8134-0f5ed0469c85
Public Version Date
December 06, 2021
Public Version Number
1
DI Record Publish Date
November 26, 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 |