| Primary Device ID | 00676190767360 |
| NIH Device Record Key | 77a312b0-6251-4122-88b7-e03c7dbc128c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One True Pair Sun |
| Version Model Number | OTPS-2042 TORTOISE |
| Catalog Number | OTPS2042S4125119C |
| 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 | 00676190767360 [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 |
| 00676190478099 | OTPS-2014 TORTOISE |
| 00676190478051 | OTPS-2014 BLUE SMOKE |
| 00676190478013 | OTPS-2014 CRYSTAL GREY |
| 00676190477733 | OTPS-2013 CREAM TORT |
| 00676190477696 | OTPS-2013 BLUSH SKY |
| 00676190477658 | OTPS-2013 MATTE BLACK |
| 00676190477610 | OTPS-2012 GOLD EMERALD |
| 00676190477573 | OTPS-2012 ROSE GOLD |
| 00676190587371 | OTPS-2015 TORTOISE |
| 00676190587333 | OTPS-2015 SAND |
| 00676190587296 | OTPS-2015 INDIGO |
| 00676190477320 | OTPS-2010 GOLD |
| 00676190477283 | OTPS-2010 ROSE GOLD |
| 00676190477245 | OTPS-2010 GUNMETAL |
| 00676190477207 | OTPS-2008 PINE GOLD |
| 00676190477160 | OTPS-2008 LAVENDER GOLD |
| 00676190477122 | OTPS-2008 MERLOT ROSE GD |
| 00676190619324 | OTPS-2020 BUTTER PECAN |
| 00676190619287 | OTPS-2020 BLUSH VIOLET |
| 00676190619249 | OTPS-2020 SKY ROSE |
| 00676190619201 | OTPS-2019 GARNET |
| 00676190619164 | OTPS-2019 GREY VIOLET |
| 00676190619126 | OTPS-2019 MATTE BLACK |
| 00676190618969 | OTPS-2016 ROSE TORTOISE |
| 00676190618921 | OTPS-2016 GREY TORTOISE |
| 00676190618884 | OTPS-2016 RUBY |
| 00676190618846 | OTPS-2018 CRIMSON GOLD |
| 00676190618808 | OTPS-2018 TEAL GOLD |
| 00676190618761 | OTPS-2018 BLACK GOLD |
| 00676190618723 | OTPS-2017 CRYSTAL HAVANA |
| 00676190618686 | OTPS-2017 GREY M.BLACK |
| 00676190618648 | OTPS-2017 MATTE NAVY TORT |
| 00676190771794 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190771756 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190771718 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190771671 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190771633 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190771596 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190770520 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190770483 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190770445 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190770148 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190770100 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190770063 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190767360 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190767322 | Sunglasses ( tinted non-prescription spectacles ) |
| 00676190767285 | Sunglasses ( tinted non-prescription spectacles ) |