| Primary Device ID | 00881814503389 |
| NIH Device Record Key | daf0fef9-5a7e-497f-bf23-f9000ca694e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IZUMI Eyewear |
| Version Model Number | OS-9236 BLACK RED |
| Company DUNS | 204096080 |
| Company Name | WestGroupe Optical Inc |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00881814503389 [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 | 2020-07-17 |
| Device Publish Date | 2020-07-09 |
| 00881814533294 | OS-9254 PEWTER |
| 00881814533256 | OS-9254 BROWN |
| 00881814533218 | OS-9254 TEAL |
| 00881814532693 | OS-9253 RED |
| 00881814532655 | OS-9253 BLACK |
| 00881814532617 | OS-9253 SILVER BLACK |
| 00881814531092 | OS-9252 MERLOT GOLD |
| 00881814531054 | OS-9252 COBALT AQUA |
| 00881814531016 | OS-9252 BLACK WHITE |
| 00881814530972 | OS-9251 RED |
| 00881814530934 | OS-9251 BROWN |
| 00881814529419 | OS-9250 SMOKE DEMI |
| 00881814529372 | OS-9250 NUDE DEMI |
| 00881814529334 | OS-9250 LAVENDER DEMI |
| 00881814528320 | OS-9247 BLACK |
| 00881814528283 | OS-9247 COBALT |
| 00881814528245 | OS-9247 BURGUNDY |
| 00881814528207 | OS-9249 TAN MESH |
| 00881814528160 | OS-9249 BERRY MESH |
| 00881814528122 | OS-9249 BLACK MESH |
| 00881814528085 | OS-9248 BROWN HONEY |
| 00881814528047 | OS-9248 BLACK LILAC |
| 00881814524032 | OS-9246 BLACK SILVER |
| 00881814523998 | OS-9246 BROWN PURPLE |
| 00881814523950 | OS-9246 COBALT AQUA |
| 00881814515337 | OS-9245 MERLOT |
| 00881814515290 | OS-9245 INK BLUE |
| 00881814515252 | OS-9245 BLACK |
| 00881814511933 | OS-9243 PURPLE FUCHSIA |
| 00881814511896 | OS-9243 WINE TANGERINE |
| 00881814511858 | OS-9243 BLACK AQUA |
| 00881814510547 | OS-9242 PECAN GOLD |
| 00881814510509 | OS-9242 VIOLET ROSE |
| 00881814506106 | OS-9241 VIOLET |
| 00881814506069 | OS-9241 EMERALD |
| 00881814506021 | OS-9241 BROWN |
| 00881814505628 | OS-9240 EGGPLANT LIME |
| 00881814505543 | OS-9240 BLACK GOLD |
| 00881814504980 | OS-9239 BROWN TURQ |
| 00881814504300 | OS-9238 FUCHSIA BLUE |
| 00881814504263 | OS-9238 BLACK ROSE |
| 00881814503549 | OS-9237 BLACK FUCHSIA |
| 00881814503501 | OS-9237 COBALT TEAL |
| 00881814503464 | OS-9236 BLACK TURQUOISE |
| 00881814503426 | OS-9236 BLACK HONEY |
| 00881814503389 | OS-9236 BLACK RED |
| 00881814503303 | OS-9233 BLACK SILVER |
| 00881814503228 | OS-9234 COBALT PURPLE |
| 00881814501231 | OS-9230 BLACK |
| 00881814501156 | OS-9230 PURPLE |