Duns Number:017535668
Device Description: The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the me The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye.
Catalog Number
CATS-D
Brand Name
CATS
Version/Model Number
CATS-D
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
Yes
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
K203850,K203850
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
b762ac31-8131-4070-b3e2-4a7f1d6ab2e1
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 2022
Package DI Number
00860412001558
Quantity per Package
4
Contains DI Package
00860412001541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |