| Primary Device ID | 04260487680102 |
| NIH Device Record Key | b437c18d-3e66-49d5-bee3-28402cae9b93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3.0T 16Ch Diagnostic Breast Coil |
| Version Model Number | P-H16LE-030-01630 |
| Company DUNS | 316037741 |
| Company Name | RAPID Biomedical GmbH |
| 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 | true |
| OTC Over-The-Counter | false |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 107 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260487680102 [Primary] |
| MOS | Coil, Magnetic Resonance, Specialty |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2019-08-23 |
| 04260487680539 - Na-140-Flex Coil | 2020-12-23 Na-140-Flex Coil |
| 04260487680546 - C-140-Flex Coil | 2020-12-23 C-140-Flex Coil |
| 04260487680232 - 1.5T Endorectal Coil | 2020-03-17 1.5T Endorectal Coil (P-Port) |
| 04260487680249 - 3.0T Endorectal Coil | 2020-03-17 3.0T Endorectal Coil |
| 04260487680416 - 1.5T Endorectal Coil | 2020-03-17 1.5T Endorectal Coil (A-Port) |
| 04260487680423 - Endorectal Coil Support | 2020-03-17 ER Coil Support |
| 04260487680430 - Endorectal Coil Screws Repair Kit | 2020-03-17 ER Coil Screws Repair Kit |
| 04260487680447 - Endorectal Coil Holder Repair Kit | 2020-03-17 ER Coil Holder Repair Kit |