| Primary Device ID | 00850042098103 |
| NIH Device Record Key | 5112224d-12c9-470b-81b2-5867a4b36650 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Template Arm |
| Version Model Number | 17279 |
| Catalog Number | 17279 |
| Company DUNS | 103665187 |
| Company Name | Promaxo, Inc. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850042098103 [Primary] |
| MOS | Coil, Magnetic Resonance, Specialty |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-08 |
| Device Publish Date | 2022-08-31 |
| 00850042098080 - MRI Large RX Coil (Receive Only) | 2022-09-08 The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil with external feedbox and fiducial co |
| 00850042098097 - MRI Medium RX Coil (Receive Only) | 2022-09-08 The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil with external feedbox and fiducial c |
| 00850042098103 - Template Arm | 2022-09-08 |
| 00850042098103 - Template Arm | 2022-09-08 |
| 00850042098042 - Fiducial Coil with Arm Mount (Receive Only) | 2022-09-07 The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be used in conjunction with the Promaxo MRI System |
| 00850042098028 - MRI Large Receive Coil | 2022-07-05 The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil to be used in conjunction with the Pr |
| 00850042098035 - MRI Medium Receive Coil | 2022-07-05 The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil to be used in conjunction with the P |
| 00860006901110 - Promaxo MRI System | 2022-04-27 Magnetic Resonance Imaging System, Magnet Cart |
| 00860006901127 - Promaxo MRI System | 2022-04-27 Magnetic Resonance Imaging System, Auxiliary Rack |