| Primary Device ID | 00857676008928 |
| NIH Device Record Key | a2d1e120-c58d-4ee7-89f8-3ea939615e6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S) |
| Version Model Number | 1028-001 |
| Catalog Number | 1028-001 |
| Company DUNS | 084330422 |
| Company Name | Eca Medical Instruments |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857676008928 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-19 |
| Device Publish Date | 2025-11-11 |
| 00850078396112 - TransLoc 3D, 18” Wire and Measurement Guide | 2025-11-25 |
| 00850078396006 - MIS Bunion - Elevator (47-0030-S) | 2025-11-19 |
| 00850078396013 - MIS Bunion Accessory Kit (47-0028-S) | 2025-11-19 |
| 00850078396020 - MIS Bunion - 2.2 x 20mm Burr (47-0029-S) | 2025-11-19 |
| 00850078396037 - MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S) | 2025-11-19 |
| 00850078396044 - MIS Bunion - 2.0mm Guide Wire (x2) (47-0032-S) | 2025-11-19 |
| 00857676008881 - Arsenal Foot™ Joint Prep Kit (330-00-100) | 2025-11-19 |
| 00857676008928 - Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S) | 2025-11-19 |
| 00857676008928 - Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S) | 2025-11-19 |