| Primary Device ID | EPTWT100380 |
| NIH Device Record Key | 54d02616-1ff3-4edf-baf8-539e4eb6ffec |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TANDEM XDR |
| Catalog Number | T10038 |
| Company DUNS | 318749751 |
| Company Name | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EPTWT100380 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-26 |
| EPTWS070031 - VERIQA | 2024-02-16 VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in ra |
| EPTWT100560 - OCTAVIUS | 2023-12-07 |
| EPTWT100570 - OCTAVIUS | 2023-12-07 |
| EPTWT100580 - OCTAVIUS | 2023-12-07 |
| EPTWS0700160 - NA | 2018-07-06 |
| EPTWS1000090 - NA | 2018-07-06 |
| EPTWT100040 - MULTIDOS | 2018-07-06 |
| EPTWT100060 - NA | 2018-07-06 |