Duns Number:017535668
Device Description: The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GAT) prism t The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GAT) prism that is optimized to work with the GAT's operating system to reduce errors in the measurement due to patient anatomical variation. This is used to measure intraocular pressure by applying a known force on the globe of the eye and measuring intraocular tension by applanation. Tonometer prisms are assembled onto a GAT as a patient contacting component that is then utilized by the GAT to assess intraocular pressure.
Catalog Number
-
Brand Name
CATS Tonometer
Version/Model Number
CATS-R
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
K173904
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
2299df90-c01c-4689-9043-f11e8516a6fe
Public Version Date
October 13, 2022
Public Version Number
2
DI Record Publish Date
January 27, 2020
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. | 24 |