| Primary Device ID | 03770020839108 |
| NIH Device Record Key | 4e8ca673-6f77-44b9-aa16-2b8ca4cb3bf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BoneMetrics US |
| Version Model Number | 1.0.X |
| Company DUNS | 281142375 |
| Company Name | GLEAMER |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |