| Primary Device ID | 00676190769371 |
| NIH Device Record Key | f35a22fb-82f3-4866-aa03-c9d35f0ef8fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fysh Sunwear |
| Version Model Number | F-2121 JADE STONE |
| Catalog Number | F2121S4165022C |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com | |
| Phone | 1-800-361-6220 |
| customerservice@westgroupe.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00676190769371 [Primary] |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-27 |
| Device Publish Date | 2024-12-19 |
| 00676190421347 | F-2055 IVORY GOLD |
| 00676190421309 | F-2055 SEAFOAM GOLD |
| 00676190421224 | F-2056 RHUBARB ROSE |
| 00676190421187 | F-2056 BROWN GOLD |
| 00676190420722 | F-2051 IVORY GOLD |
| 00676190420685 | F-2051 PINK HAVANA |
| 00676190420647 | F-2051 BLACK GOLD |
| 00676190419283 | F-2054 HAVANA GOLD |
| 00676190419245 | F-2054 SEAFOAM SILVER |
| 00676190419207 | F-2054 ROSE |
| 00676190419047 | F-2052 TROPIC GREEN |
| 00676190419009 | F-2052 TROPIC PINK |
| 00676190418125 | F-2050 PLUM GOLD |
| 00676190418088 | F-2050 BLACK GOLD |
| 00676190417807 | F-2046 PURPLE SHIMMER |
| 00676190417760 | F-2046 GREY SHIMMER |
| 00676190417722 | F-2046 PECAN SHIMMER |
| 00676190417555 | F-2048 RASPBERRY GOLD |
| 00676190417517 | F-2048 OCEAN ROSE GOLD |
| 00676190417470 | F-2048 BLACK GOLD |
| 00676190417432 | F-2049 SAND GOLD |
| 00676190417395 | F-2049 SEAFOAM GOLD |
| 00676190417357 | F-2049 LEOPARD GOLD |
| 00676190416824 | F-2047 NUDE IVORY |
| 00676190416787 | F-2047 GREY TURQUOISE |
| 00676190416435 | F-2045 BLUSH ROSE GOLD |
| 00676190416398 | F-2045 SEAFOAM GOLD |
| 00676190416350 | F-2045 BROWN GOLD |
| 00676190416312 | F-2044 GREY CARAMEL |
| 00676190416275 | F-2044 BROWN AQUA |
| 00676190416237 | F-2044 SAPPHIRE ROSE |
| 00676190414707 | F-2042 BROWN SMOKE |
| 00676190414660 | F-2042 ROSE SMOKE |
| 00676190414622 | F-2042 AQUA SMOKE |
| 00676190414585 | F-2043 SUNSET GOLD |
| 00676190414547 | F-2043 OCEAN TURQ |
| 00676190414509 | F-2043 BROWN STR GOLD |
| 00676190370645 | F-2041 BLUSH GOLD |
| 00676190370607 | F-2041 MINT CHROME |
| 00676190370560 | F-2041 LAVENDER ROSE |
| 00676190362626 | F-2040 ROSE GREY |
| 00676190362589 | F-2040 LAVENDER PINK |
| 00676190362541 | F-2040 SKY NUDE |
| 00676190361322 | F-2038 PURPLE LEOPARD |
| 00676190361285 | F-2038 CHAMELEON |
| 00676190361247 | F-2038 SNAKESKIN |
| 00676190361209 | F-2039 WHITE GOLD |
| 00676190361162 | F-2039 OCEAN GUN |
| 00676190361124 | F-2039 TOFFEE GOLD |
| 00676190361087 | F-2037 ROSE BERRY |