| Primary Device ID | 00857676008812 |
| NIH Device Record Key | 1d906995-64de-4aa5-bf3c-c2c5b114efd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fracture Reduction Guide Accessory Pack |
| Version Model Number | 1012 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857676008812 [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 | 2025-06-25 |
| Device Publish Date | 2025-06-17 |
| 00857676008744 - 2.0MM Drill Accessory Pack | 2025-06-25 |
| 00857676008751 - 2.7MM Drill Accessory Pack | 2025-06-25 |
| 00857676008768 - 3.0MM Drill Accessory Pack | 2025-06-25 |
| 00857676008775 - T8 Driver Accessory Pack | 2025-06-25 |
| 00857676008782 - Depth Gauge Accessory Pack | 2025-06-25 |
| 00857676008799 - Metacarpal Intramedullary Nail Surgery Ready Instrument Kit | 2025-06-25 |
| 00857676008805 - K-Wire Accessory Pack | 2025-06-25 |
| 00857676008812 - Fracture Reduction Guide Accessory Pack | 2025-06-25 |
| 00857676008812 - Fracture Reduction Guide Accessory Pack | 2025-06-25 |