| Primary Device ID | 00840682116978 |
| NIH Device Record Key | 3936b9bc-1347-4b36-81d3-47032261b4e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Achilles EXPII |
| Version Model Number | v1 |
| Company DUNS | 654658731 |
| Company Name | GE Medical Systems (China) 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682116978 [Primary] |
| MUA | Bone sonometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-12 |
| Device Publish Date | 2016-06-27 |
| 00195278690388 - Versana | 2024-11-05 Magna R3 VS Basic console |
| 00195278690395 - Versana | 2024-11-05 Magna R3 VA Basic console |
| 00195278466471 - NA | 2024-06-07 L4-20t-D |
| 00195278674197 - LOGIQ | 2023-12-28 LOGIQ e TP Standard Console |
| 00195278674203 - LOGIQ | 2023-12-28 LOGIQ e TB Standard Console |
| 00195278300034 - Versana | 2023-06-23 Supra R2 basic console for Balance VS |
| 00195278300096 - Versana | 2023-06-23 Supra R2 basic console for Balance VA |
| 00195278503404 - Versana | 2023-06-21 Versana Essential R2 VS |