| Primary Device ID | 04056481002589 |
| NIH Device Record Key | 8da98a8d-67bc-4fcf-8208-15d795d5b677 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Frameless Radiosurgery Components |
| Version Model Number | 43405-01A |
| Catalog Number | 43405-01A |
| Company DUNS | 314482980 |
| Company Name | Brainlab AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +49899915680 |
| contact@brainlab.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056481002589 [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 | 2016-09-15 |
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| 04056481144845 - Automatic Registration iMRI | 2023-11-28 Automatic Registration iMRI provides an automatic image registration for cranial indications. |
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| 04056481145217 - DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS) | 2023-10-25 |
| 04056481145392 - DRAPELINK REF ADAPTER AUTO-REG IMRI | 2023-10-24 |
| 04056481145101 - Automatic Registration | 2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA |
| 04056481143138 - Drill Bit Cranial 2.4/4.0 | 2023-09-26 |