| Primary Device ID | 05704916000622 |
| NIH Device Record Key | f7f80deb-73ff-4d8a-a2b9-0307d6cbad75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Small Footprint Cardiac Transducer |
| Version Model Number | 8837 |
| 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 | true |
| 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 |
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| 05704916001407 - Non-implantable, needle guide, reusable | 2019-12-23 Reusable Transperineal Needle Guide |