Duns Number:317138956
Device Description: The OCULUS Keratograph 5M combines the keratometric measuring processwith topographic mapp The OCULUS Keratograph 5M combines the keratometric measuring processwith topographic mapping.Measurement of the corneal surface is done by means of a Placido ringsystem that is reflected off the cornea. These data are analyzed by thecomputer.
Catalog Number
-
Brand Name
Keratograph 5M
Version/Model Number
7700
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
1ca9393f-84b4-4601-afd6-6ef12318353a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |