Duns Number:522052554
Device Description: The PTS 920BY automated projection perimeter is a diagnostic instrument designed for visua The PTS 920BY automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.
Catalog Number
760-002
Brand Name
Automated Perimeter
Version/Model Number
PTS 920BY
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
-
Product Code
HPT
Product Code Name
Perimeter, Automatic, Ac-Powered
Public Device Record Key
198cf733-5295-4d61-a571-8293086b60fd
Public Version Date
August 01, 2022
Public Version Number
2
DI Record Publish Date
March 09, 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 | 6 |