| Primary Device ID | 00860003072769 |
| NIH Device Record Key | 7f182c60-69c5-4182-8f73-4eb84d97383a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BMT Fiducial Needle, Round |
| Version Model Number | 80-FN1720 |
| Company DUNS | 056124661 |
| Company Name | CONCURE ONCOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00860003072769 [Primary] |
| IWJ | System, Applicator, Radionuclide, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-13 |
| Device Publish Date | 2020-08-05 |
| 00860005821204 - Obturator and Caps | 2021-04-27 |
| 00860005821211 - BMT Localizer Needle Kit | 2021-04-27 |
| 00860003072714 - BMT Template Grid Armature & Table Clamp | 2020-08-13 |
| 00860003072721 - BMT Armrest Armature & Table Clamp | 2020-08-13 |
| 00860003072738 - BMT Template Grid, Vertical Lock, Large | 2020-08-13 |
| 00860003072745 - BMT Cleaning Brush Set, Vertical Lock | 2020-08-13 |
| 00860003072752 - BMT Fiducial Needle, Sharp | 2020-08-13 |
| 00860003072769 - BMT Fiducial Needle, Round | 2020-08-13 |
| 00860003072769 - BMT Fiducial Needle, Round | 2020-08-13 |