| Primary Device ID | 00193033321997 |
| NIH Device Record Key | bf07e564-5e4d-4d09-8f4a-037e98e65a8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASSORTED BRANDS |
| Version Model Number | DL5349/36.CGR |
| Company DUNS | 062312087 |
| Company Name | FGX INTERNATIONAL 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(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com | |
| Phone | +1(401)231-3800 |
| Customerservices@fgxi.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193033321997 [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 | 2022-02-07 |
| Device Publish Date | 2022-01-30 |