| Primary Device ID | 00857676008867 |
| NIH Device Record Key | 70d0c231-f40d-4b09-8af9-7d6da1d0bf89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ActivaScrew™ Cannulated Single-Use Instrument Kit (4.5MM) |
| Version Model Number | 1013-003 |
| 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 | 00857676008867 [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 | 2025-06-24 |
| Device Publish Date | 2025-06-16 |
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| 00857676008850 - ActivaScrew™ Cannulated Single-Use Instrument Kit (4.0MM) | 2025-06-24 |
| 00857676008867 - ActivaScrew™ Cannulated Single-Use Instrument Kit (4.5MM) | 2025-06-24 |
| 00857676008867 - ActivaScrew™ Cannulated Single-Use Instrument Kit (4.5MM) | 2025-06-24 |
| 00857676008669 - Orthopedic Cannulated Nail Instrument Pack | 2025-06-12 |
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| 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 |