| Primary Device ID | EIBASC020000 |
| NIH Device Record Key | 927ac760-6419-45da-b9ac-7f8ecd53f8e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smartscan Waterphantom |
| Version Model Number | SC02-000 |
| Company DUNS | 332599307 |
| Company Name | IBA Dosimetry 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 | false |
| 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 |
| Phone | +49912860738 |
| service@iba-group.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EIBASC020000 [Primary] |
| IYE | Accelerator, Linear, 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 | 2019-01-04 |
| Device Publish Date | 2018-12-04 |
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| EIBAHA03010V0040 - Lift table | 2023-09-27 Electric Lift Table Type 115V |
| EIBAHA050000 - Water Reservoir | 2023-08-11 Waterreservoir - bidirectional pump, 230V |
| EIBAHA050100 - Water Reservoir | 2023-08-11 Waterreservoir - bidirectional pump, 115V |
| EIBAE30702001 - myQA SRS Detector Cyberknife edition | 2023-08-02 myQA SRS Cyberknife edition |
| EIBAE20702000 - DOSE-X | 2023-04-21 DOSE-X Dosimeter TNC |
| EIBAE20703000 - DOSE-X | 2023-04-21 DOSE-X Dosimeter BNC |