| Primary Device ID | 07484743197150 |
| NIH Device Record Key | 17f2cfe6-5690-4be6-80ec-dba13cf37bdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EYEWEAR BY ROI MASSY TORTOISE |
| Version Model Number | 1 |
| Company DUNS | 177953189 |
| Company Name | Eyewear By Roi, Limited |
| 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 | false |
| 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 | 07484743197150 [Primary] |
| HQZ | Frame, spectacle |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-18 |
| Device Publish Date | 2022-07-08 |
| 07484743197150 | 53-16-135 TORTOISE BULOVA EYEWEAR |
| 00748474319715 | 53-16-135 TORTOISE BULOVA EYEWEAR |