| Primary Device ID | 05057056905709 |
| NIH Device Record Key | 07a76e72-532e-4882-87b5-a0f9031f92c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTOS ADVANCE |
| Version Model Number | S90570 |
| Company DUNS | 346013337 |
| Company Name | OPTOS PUBLIC LIMITED COMPANY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05057056905709 [Primary] |
| NFJ | System, Image Management, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2016-05-27 |
| 05057056107509 - OCT Ophthalmoscope | 2019-11-06 A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical c |
| 05057056905709 - OPTOS ADVANCE | 2018-09-24 |
| 05057056905709 - OPTOS ADVANCE | 2018-09-24 |
| 05057056003856 - Optos OCT/SLO | 2018-07-06 |
| 05057056100920 - Panoramic Opthalmoscope | 2018-07-06 |
| 05057056107004 - OCT Ophthalmoscope | 2018-05-03 The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and dig |
| 05057056010212 - Panoramic Ophthalmoscope | 2018-03-29 |
| 05057056100210 - Panoramic Ophthalmoscope | 2018-03-29 |
| 05057056106007 - Panoramic Ophthalmoscope | 2018-03-29 |