| Primary Device ID | 00857534006387 |
| NIH Device Record Key | e0d31ba9-9c3e-4979-ba61-81c4ecb35862 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InSitu Coil, 1.5T |
| Version Model Number | InSitu Coil, Open, 1.5T |
| Company DUNS | 079990922 |
| Company Name | DEERFIELD IMAGING, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00857534006387 [Primary] |
| GS1 | 10857534006384 [Package] Package: Case [5 Units] In Commercial Distribution |
| MOS | Coil, Magnetic Resonance, Specialty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2016-11-23 |
| 00857534006837 - Horseshoe Headrest | 2024-11-11 Horseshoe Headrest Starter Kit, HFD 100 |
| 00857534006844 - Horseshoe Headrest | 2024-11-11 Horseshoe Headrest Starter Kit, HFD 200 |
| 00857534006271 - VISIUSeye | 2024-10-14 VISIUSeye - iMRI 1.5T E |
| 00857534006295 - VISIUSeye | 2024-10-14 VISIUSeye - iMRI 3T V |
| 00857534006301 - VISIUSeye | 2024-10-14 VISIUSeye - iCT 64 |
| 00857534006363 - VISIUSmatrix | 2024-10-14 Application Platform 2.4 NA |
| 00857534006455 - MR/X-ray HFD (HFD 200) | 2024-10-14 MR/X-ray Head Fixation Device (HFD 200) |
| 00857534006585 - VISIUSeye | 2024-10-14 VISIUSeye, iMRI 3T V |