| Primary Device ID | D7751910261 |
| NIH Device Record Key | 54eb43b5-cb97-4db8-982c-c2706e05c06c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLO MOUTHGUARD BLACK (DZ) * |
| Version Model Number | 191-026 |
| Catalog Number | 191-026 |
| Company DUNS | 041854332 |
| Company Name | GREAT LAKES ORTHODONTICS, LTD. |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |