| Primary Device ID | 00857676008638 |
| NIH Device Record Key | c5144cdd-a3ae-4d23-9e0f-61d054563a41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Threaded Trimmable Fixation Nail Instrument Pack 5.5 |
| Version Model Number | 5.5 Instrument Pack |
| Catalog Number | 967-004 |
| 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 | 00857676008638 [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 | 2024-10-29 |
| Device Publish Date | 2024-10-21 |
| 00857676008232 - Stryker | 2025-04-10 |
| 00857676008737 - TruTorq Adaptor Sterile, Single Use | 2025-03-17 |
| 00857676008676 - Revcon Instrument Kit, Sterile | 2025-03-11 |
| 00857676008683 - Revcon Instrument Kit, Sterile | 2025-03-11 |
| 00857676008690 - Shannon Bur, Sterile | 2025-03-11 |
| 00857676008706 - Wedge Bur, Sterile | 2025-03-11 |
| 00857676008638 - Threaded Trimmable Fixation Nail Instrument Pack 5.5 | 2024-10-29 |
| 00857676008638 - Threaded Trimmable Fixation Nail Instrument Pack 5.5 | 2024-10-29 |
| 00857676008201 - TruFIX | 2024-07-25 |