| Primary Device ID | 05903293141137 |
| NIH Device Record Key | 198cf733-5295-4d61-a571-8293086b60fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Automated Perimeter |
| Version Model Number | PTS 920BY |
| Company DUNS | 522052554 |
| Company Name | OPTOPOL TECHNOLOGY SP Z O O |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05903293141137 [Primary] |
| HPT | Perimeter, Automatic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-09 |
| Device Publish Date | 2018-03-09 |
| 05903293141168 | The PTS 925BY automated perimeter is a diagnostic instrument designed for visual field testing. |
| 05903293141151 | The PTS 925W automated perimeter is a diagnostic instrument designed for visual field testing. T |
| 05903293141144 | The PTS 925 automated perimeter is a diagnostic instrument designed for visual field testing. Th |
| 05903293141137 | The PTS 920BY automated projection perimeter is a diagnostic instrument designed for visual fiel |
| 05903293141120 | The PTS 920 automated perimeter is a diagnostic instrument designed for visual field testing. Th |