| Primary Device ID | 04056481000530 |
| NIH Device Record Key | 14bd90eb-d480-4700-a23c-1b4cccd2fbd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RT Elements - Cranial SRS w/ Cones |
| Version Model Number | 3.0 |
| 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 | 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 |
|---|---|
| GS1 | 04056481000530 [Primary] |
| MUJ | System, Planning, Radiation Therapy Treatment |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2021-08-27 |
| 04056481146672 - Mixed Reality Spine Navigation | 2025-08-08 |
| 04056481145941 - Disposable Loop-X Source Drape (1 Pc) | 2025-08-04 The source drape is intended to sterile cover the source (cone beam) of the Loop-X. |
| 04056481145330 - CRANIAL 4PI HEADREST PLATFORM | 2025-07-04 |
| 04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD | 2025-07-04 |
| 04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.) | 2025-07-04 |
| 04056481145361 - CRANIAL 4PI WEDGE 10 DEG. | 2025-07-04 |
| 04056481145378 - CRANIAL 4PI SPACER 20MM | 2025-07-04 |
| 04056481145453 - CRANIAL 4PI INDEXING PLATE | 2025-07-04 |