| Primary Device ID | 08012794011461 | 
| NIH Device Record Key | 25819dd4-8f73-472c-a6a8-d5b650bee514 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | BLUEOTTER | 
| Version Model Number | PLASTIC SUNGLASSES | 
| Company DUNS | 428689665 | 
| Company Name | LA GIARDINIERA SRL | 
| 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 | 08012794011461 [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 | 2023-01-13 | 
| Device Publish Date | 2023-01-05 | 
| 08012794011942 - ANGELEONE | 2024-10-14 PLASTIC FRAME WITH SUNLENSES | 
| 08012794011959 - LIFE ITALIA | 2024-10-14 OPTICAL FRAME | 
| 08012794011966 - LIFE ITALIA | 2024-10-14 OPTICAL FRAME | 
| 08012794011973 - LIFE ITALIA | 2024-10-14 OPTICAL FRAME | 
| 08012794011980 - LIFE ITALIA | 2024-10-14 OPTICAL FRAME | 
| 08012794011997 - LIFE ITALIA | 2024-10-14 OPTICAL FRAME | 
| 08012794012000 - LIFE ITALIA | 2024-10-14 OPTICAL FRAME | 
| 08012794012017 - VELENCI | 2024-10-14 PLASTIC FRAME WITH SUNLENSES | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BLUEOTTER  85716511  4956148 Live/Registered | Sobota International Associates 2012-08-29 |