Duns Number:492566474
Device Description: Cassini is a Corneal Topography System. An assembly of ophthalmic devices used to measure Cassini is a Corneal Topography System. An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface.
Catalog Number
-
Brand Name
CASSINI
Version/Model Number
2.0,3.0
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
-
Product Code
MMQ
Product Code Name
Topographer, Corneal, Ac-Powered
Public Device Record Key
a311ee15-1342-4ae5-a917-ead1ad3146d2
Public Version Date
March 11, 2021
Public Version Number
1
DI Record Publish Date
March 03, 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 | 1 |