| Primary Device ID | 04056481094843 |
| NIH Device Record Key | 537faba6-a8ad-4078-ae38-841e48213b3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLUORO 3D-2D UPGRADE KIT (FOR 3D C-ARMS) |
| Version Model Number | 55715-20 |
| 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 | 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 | +49899915680 |
| contact@brainlab.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056481094843 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-08-03 |
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| 04056481146320 - Alignment Software Spine | 2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme |
| 04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K) | 2025-06-23 |
| 04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) | 2025-06-23 |
| 04056481145828 - Microscope Navigation | 2025-06-19 |
| 04056481143985 - Mixed Reality Spine Navigation | 2025-06-09 |
| 04056481140809 - Curve 1.2 Dual Navigation Station | 2025-03-26 |