| Primary Device ID | 04056481143824 |
| NIH Device Record Key | 8c90f6aa-4eb8-4b9d-b581-54eca650a7ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brainlab Elements BOLD MRI Mapping |
| Version Model Number | 1.0 |
| Company DUNS | 314482980 |
| Company Name | Brainlab AG |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056481143824 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-28 |
| Device Publish Date | 2023-07-20 |
| 04056481145514 - Z-touch Laser Registration Pointer | 2025-02-21 The Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration w |
| 04056481144906 - Spine &Trauma Navigation | 2024-11-22 |
| 04056481146238 - PATIENT REFERENCE ARRAY SPINE & TRAUMA | 2024-11-22 |
| 04056481146603 - ADAPTER SHORT FOR PATIENT REFERENCE CLAMP | 2024-11-22 |
| 04056481146610 - ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY | 2024-11-22 |
| 04056481143916 - Spine Planning | 2024-11-13 |
| 04056481144654 - Viewer 5.4 | 2024-11-13 |
| 04056481143527 - DICOM Proxy | 2024-11-01 |