| Primary Device ID | 05704916000264 |
| NIH Device Record Key | 71faf51b-4bae-4c4c-af12-be821d5d6da1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | bk3000, bk3500 & bk5000 Ultrasound System |
| Version Model Number | 2300 |
| Company DUNS | 310093901 |
| Company Name | Bk Medical ApS |
| 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 |
| 05704916001711 - I13C3fx Transducer | 2023-06-22 Tracked Laparoscopic Intraoperative Transducer -with
build-in tracking internal sensor |
| 05704916001667 - Non-implantable needle guide, single-use | 2022-12-15 Disposable 18g Transperineal Needle Guide |
| 05704916001698 - Non-implantable needle guide, single-use | 2022-12-15 Non-implantable needle guide, single-use |
| 05704916001599 - Rob12C4 | 2022-05-31 The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted p |
| 05704916000240 - I13C3f Transducer | 2020-04-03 Intraoperative |
| 05704916001131 - N20P6 Transducer | 2020-04-03 High resolution, mini footprint, Intraoperative (neuro) imaging |
| 05704916001315 - I12C5 transducer | 2020-04-03 Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial) |
| 05704916001407 - Non-implantable, needle guide, reusable | 2019-12-23 Reusable Transperineal Needle Guide |