| Primary Device ID | 00840682146302 |
| NIH Device Record Key | bac63578-563a-4b08-8de0-34d9b6cce479 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SIGNA Prime |
| Company DUNS | 421356265 |
| Company Name | GE Medical Systems (Tianjin) Co., Ltd. |
| 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 | true |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00840682146302 [Primary] |
| LNH | System, nuclear magnetic resonance imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-15 |
| Device Publish Date | 2022-03-07 |
| 00195278707871 - NA | 2024-02-13 SIGNA Champion System Medical Device |
| 00195278629234 - NA | 2023-08-14 SIGNA Voyager 1.5T Detachable Table - Wireless Gating |
| 00195278616845 - NA | 2023-03-20 SIGNA Victor System Medical Device |
| 00195278481382 - NA | 2022-09-16 SIGNA Artist Evo System Medical Device, MDR |
| 00840682146302 - NA | 2022-03-15SIGNA Prime System Medical Device |
| 00840682146302 - NA | 2022-03-15 SIGNA Prime System Medical Device |
| 00195278372307 - NA | 2021-06-23 Voyager AIR Medical Device Assembly |
| 00195278248923 - NA | 2021-05-04 SIGNA Voyager 1.5T Detachable Table Assembly |
| 00195278124609 - NA | 2021-02-10 Kizuna System Medical Device Assembly-MDR |