| Primary Device ID | 00860009734821 |
| NIH Device Record Key | dbc02ccb-1bb9-4c2c-b3af-02aa822e5669 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Artemis-TPOS |
| Version Model Number | 1.0 |
| Catalog Number | 900-20000-02 |
| Company DUNS | 117062155 |
| Company Name | Eigen Health Services LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009734821 [Primary] |
| GEH | Unit, Cryosurgical, Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
| 00860009734807 - ProFuse | 2026-02-05 MRI annotation and analysis tool |
| 00860009734814 - Artemis | 2026-02-05 3D workstation for Transrectal/transperineal biopsy navigation and planning of the prostate. |
| 00860009734821 - Artemis-TPOS | 2026-02-053D workstation for transperineal only biopsy navigation and planning of the prostate. |
| 00860009734821 - Artemis-TPOS | 2026-02-05 3D workstation for transperineal only biopsy navigation and planning of the prostate. |
| 00860009734838 - Artemis with ProFuse | 2024-12-30 Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostat |