Duns Number:078605507
Device Description: IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the extent and axis of astigmatism.
Catalog Number
-
Brand Name
IBEX Keratometer
Version/Model Number
MK
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
-
Product Code
HLQ
Product Code Name
Keratoscope, Ac-Powered
Public Device Record Key
044a31e8-d075-44f1-a31e-a1a22ac72451
Public Version Date
August 09, 2019
Public Version Number
3
DI Record Publish Date
January 01, 2018
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |