| Primary Device ID | 00858164002206 |
| NIH Device Record Key | 549083fd-f5c9-4576-9ec7-312ae2043d56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERGO++ |
| Version Model Number | ERGO++ |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858164002206 [Primary] |
| MUJ | System,Planning,Radiation Therapy Treatment |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-05 |
| Device Publish Date | 2017-11-10 |
| 00858164002381 - Aqua | 2023-06-30 |
| 00858164002367 - MOSAIQ | 2021-12-10 |
| 00858164002336 - MOSAIQ | 2019-11-08 |
| 00858164002275 - Monaco | 2019-10-25 |
| 00858164002237 - MOSAIQ | 2019-08-12 |
| 00858164002251 - MOSAIQ | 2019-08-12 |
| 00858164002039 - Atlas-Based Autosegmentation | 2019-08-05 |
| 00858164002114 - XiO | 2019-08-05 |