| Primary Device ID | 00858991006088 |
| NIH Device Record Key | c19bbbe3-7f76-40bb-bc04-cdcc6598a778 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProBeam 360 Proton Therapy System - Rotating Gantry |
| Version Model Number | 2.0 |
| Company DUNS | 342623907 |
| Company Name | Varian Medical Systems Particle Therapy GmbH |
| 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 | true |
| Manufacturing Date | true |
| 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 | 00858991006088 [Primary] |
| LHN | System, radiation therapy, charged-particle, medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
| 00858991006088 - ProBeam 360 Proton Therapy System - Rotating Gantry | 2023-11-02 |
| 00858991006088 - ProBeam 360 Proton Therapy System - Rotating Gantry | 2023-11-02 |
| 00858991006071 - ProBeam 360 Proton Therapy System - Rotaiting Gantry | 2022-12-14 |
| 00858991006026 - ProBeam® Fixed Beam Proton Therapy System | 2019-10-04 Fixed Beam |
| 00858991006033 - ProBeam® Rotating Gantry Proton Therapy System | 2019-10-04 Rotating Gantry |
| 00858991006040 - ProBeam® Rotating Gantry Proton Therapy System | 2019-10-04 |
| 00858991006002 - ProBeam Proton Therapy System | 2018-07-06 Rotating Gantry |
| 00858991006019 - ProBeam Proton Therapy System | 2018-07-06 Fixed Beam |