| Primary Device ID | 04056481139292 |
| NIH Device Record Key | c36df7a4-16db-4ee3-a71e-da42930b9038 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPARE WEDGE, SPINE REFERENCE CLAMP |
| Version Model Number | 55758-10 |
| Catalog Number | 55758-10 |
| 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 | 04056481139292 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04056481139292]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2017-08-04 |
| 04056481143916 - Spine Planning | 2024-11-13 |
| 04056481144654 - Viewer 5.4 | 2024-11-13 |
| 04056481143527 - DICOM Proxy | 2024-11-01 |
| 04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.) | 2024-07-26 |
| 04056481144920 - CRANIAL 4PI STEREOTACTIC MASK (1 PC.) | 2024-07-26 |
| 04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.) | 2024-07-26 |
| 04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.) | 2024-07-26 |
| 04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.) | 2024-07-26 |