| Primary Device ID | 04260184512218 |
| NIH Device Record Key | 277a3f49-60a9-428b-b8dd-34380d64863d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | plusoptiX 12 |
| Version Model Number | S12C |
| Company DUNS | 332755078 |
| Company Name | Plusoptix GmbH |
| 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 | false |
| 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 | 04260184512218 [Primary] |
| GS1 | 04260184512225 [Package] Package: [2 Units] In Commercial Distribution |
| HKO | Refractometer, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-28 |
| Device Publish Date | 2022-10-20 |
| 04260184513215 | The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil di |
| 04260184513116 | The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil di |
| 04260184512218 | The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil di |
| 04260184512119 | The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil di |