Duns Number:078605507
Device Description: IBEX Tonometer is used for determining intraocular tension by measuring the pressure requi IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.
Catalog Number
-
Brand Name
Applanation Tonometer
Version/Model Number
AT
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
K023676
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
4951d709-bb91-49aa-aa54-6597132972f6
Public Version Date
July 06, 2018
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 |