Duns Number:126650253
Device Description: Non-active, contact applanation tonometer intended to measure intraocular pressure of the Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye.
Catalog Number
-
Brand Name
CT210 Contact Tonometer
Version/Model Number
12598
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
K000288
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
0485384d-97b9-44ba-9b14-e53aaeed1d1b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |