| Primary Device ID | 00842000100713 |
| NIH Device Record Key | 2308876c-82ce-42a4-80ca-96c6060a1e87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Merge OrthoCase |
| Version Model Number | 3.7.5 |
| Company DUNS | 065626069 |
| Company Name | MERGE HEALTHCARE SOLUTIONS INC. |
| 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 | 00842000100713 [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 | 2 |
| Public Version Date | 2019-05-09 |
| Device Publish Date | 2018-09-21 |
| 00842000101123 - Merge Cardio | 2024-02-13 Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management syste |
| 00842000101147 - Merge PACS | 2023-12-06 |
| 00842000101086 - Merge PACS | 2023-09-22 |
| 00842000101130 - Merge Universal Viewer | 2023-09-07 |
| 00842000100904 - Merge OrthoTemplates | 2023-06-19 Software implant template |
| 00842000101093 - Merge Universal Viewer | 2023-03-27 |
| 00842000101116 - CADstream | 2023-03-15 Standalone software application |
| 00842000100003 - CADstream | 2021-09-29 Standalone Software Application |