| Primary Device ID | E314SURGICASEVIEWER0 |
| NIH Device Record Key | a7d94176-82bf-4260-9a64-a65815ffb5fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiCase Viewer |
| Version Model Number | SurgiCase Viewer |
| Catalog Number | SurgiCase Viewer |
| Company DUNS | 373139427 |
| Company Name | Materialise NV |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E314SURGICASEVIEWER0 [Primary] |
| LLZ | System, Image Processing, Radiological |
| 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 | 2017-06-16 |
| 05404028000922 - SurgiCase Planner | 2025-05-22 SurgiCase Knee Planner |
| 05404028000946 - Materialise Mimics Enlight CMF | 2025-05-20 Materialise Mimics Enlight CMF Orthognathic and Trauma Planner |
| 05404028000953 - Materialise Mimics Enlight CMF | 2025-05-20 Mimics Enlight CMF Reconstruction Planner |
| 05404028000199 - Materialise Mimics Enlight | 2025-03-17 Materialise Mimics Enlight |
| 05404028000281 - SurgiCase OOS | 2025-03-17 SurgiCase Mobile |
| 05420060380747 - TRUMATCH | 2025-03-10 Titanium 3D Printed Guide, Bone harvesting |
| 05420060380754 - TRUMATCH | 2025-03-10 Mandible Reconstruction kit |
| 05420060380761 - TRUMATCH | 2025-03-10 Midface Reconstruction kit |