| Primary Device ID | 00850038195557 |
| NIH Device Record Key | 8d51c4f0-e9aa-4482-8997-e9d79f9ac7e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LuxVsion |
| Version Model Number | LDR-7800 |
| Catalog Number | LDR-7800 |
| Company DUNS | 166760392 |
| Company Name | U.S. OPHTHALMIC, L.L.C. |
| 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 | true |
| 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 | 00850038195557 [Primary] |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-16 |
| Device Publish Date | 2024-04-08 |
| 00850038195557 - LuxVsion | 2024-04-16Luxvision Digital Refractor LDR-7800 |
| 00850038195557 - LuxVsion | 2024-04-16 Luxvision Digital Refractor LDR-7800 |
| 00851158007805 - Eli Ezer | 2024-04-16 Digital Refractor Ezer EDR-H |
| 00851158007836 - Eli Ezer | 2024-04-16 Digital Refractor Ezer EDR-9000 A |
| 00850038195335 - Eli Ezer | 2024-04-11 EZ-OPH-3600 ophthalmoscope HALOGEN Lamp |
| 00850038195342 - Eli Ezer | 2024-04-11 EZ-OPH-3600 ophthalmoscope LED Lamp |
| 00851158007621 - Eli Ezer | 2024-02-02 ESL-Emerald-1 |
| 00851158007638 - Eli Ezer | 2024-02-02 ESL-Emerald-8 |
| 00851158007645 - Eli Ezer | 2024-02-02 ESL-Emerald-18 |