| Primary Device ID | 00858164002213 |
| NIH Device Record Key | 10da6a3d-c092-4b44-9250-fd891b5edfed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERGO Localizer |
| Version Model Number | ERGO Localizer |
| Company DUNS | 079089435 |
| Company Name | ELEKTA, INC. |
| 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 | true |
| 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 |