| Primary Device ID | 18435736077665 |
| NIH Device Record Key | 8769e27e-1e7e-4a79-9f4a-57853daa4e7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ETNIA EYEWEAR CULTURE |
| Version Model Number | 5 KOALA 46S BLTQ |
| Company DUNS | 148350593 |
| Company Name | Etnia Barcelona, Llc. |
| 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es | |
| Phone | +1(305)879-1094 |
| anita.haudebert@etnia.es |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08435736077668 [Primary] |
| GS1 | 18435736077665 [Package] Contains: 08435736077668 Package: Box [8 Units] In Commercial Distribution |
| 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 | 2025-02-03 |
| Device Publish Date | 2025-01-24 |
| 18435685098834 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685098773 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685098711 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685098650 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685098599 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685098537 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685098476 | Sunglasses (non-prescription including photosensitive) |
| 18435685098414 | Sunglasses (non-prescription including photosensitive) |
| 18435685098353 | Sunglasses (non-prescription including photosensitive) |
| 18435685098292 | Sunglasses (non-prescription including photosensitive) |
| 18435685098230 | Sunglasses (non-prescription including photosensitive) |
| 18435685098179 | Sunglasses (non-prescription including photosensitive) |
| 18435685098117 | Sunglasses (non-prescription including photosensitive) |
| 18435685098056 | Sunglasses (non-prescription including photosensitive) |
| 18435685097998 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097936 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097875 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097813 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097752 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097691 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097639 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097578 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097516 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097455 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097394 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097332 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097271 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097219 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097158 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097097 | Sunglasses (non-prescriptionincluding photosensitive) |
| 18435685097042 | Frame Spectacle |
| 18435685097004 | Frame Spectacle |
| 18435685096960 | Frame Spectacle |
| 18435685096922 | Frame Spectacle |
| 18435685096885 | Frame Spectacle |
| 18435685096847 | Frame Spectacle |
| 18435685096809 | Frame Spectacle |
| 18435685096762 | Frame Spectacle |
| 18435685096724 | Frame Spectacle |
| 18435685096687 | Frame Spectacle |
| 18435685096649 | Frame Spectacle |
| 18435685096601 | Frame Spectacle |
| 18435685096083 | Frame Spectacle |
| 18435685096045 | Frame Spectacle |
| 18435685096007 | Frame Spectacle |
| 18435685095963 | Frame Spectacle |
| 18435685095925 | Frame Spectacle |
| 18435685095888 | Frame Spectacle |
| 18435685095840 | Frame Spectacle |
| 18435685095802 | Frame Spectacle |