| Primary Device ID | 05404028000199 |
| NIH Device Record Key | 0d175656-312f-4b1d-8de0-d45215af06cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Materialise Mimics Enlight |
| Version Model Number | Materialise Mimics Enlight |
| Catalog Number | Materialise Mimics Enlight |
| 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 | 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 | 05404028000199 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-17 |
| Device Publish Date | 2025-03-07 |
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| 05420060380853 - TRUMATCH | 2025-09-19 TRUMATCH TJR Midface Titanium Kit |
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