| Primary Device ID | 04056869231211 |
| NIH Device Record Key | 99c618ff-01cd-4c3a-96f2-2191b38db85b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTX Extremity 18 Flare Coil set 1.5T |
| Version Model Number | 11293129 |
| Company DUNS | 544891302 |
| Company Name | Siemens Shenzhen Magnetic Resonance 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 | false |
| 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 | 04056869231211 [Primary] |
| LNI | System, nuclear magnetic resonance spectroscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-09 |
| Device Publish Date | 2021-07-30 |
| 04056869281759 - MAGNETOM Free.Max | 2022-09-09 |
| 04056869281766 - MAGNETOM Free.Star | 2022-09-09 |
| 04056869281773 - MAGNETOM Free.Star | 2022-09-09 |
| 04056869281926 - Contour M Coil Set | 2022-09-09 |
| 04056869281742 - MAGNETOM Free.Max | 2021-08-10 MRI Scanner |
| 04056869281858 - Head/Neck Coil | 2021-08-10 |
| 04056869281896 - Head/Neck Coil Set | 2021-08-10 |
| 04056869281933 - Spine Coil | 2021-08-10 |