| Primary Device ID | 00850078396136 |
| NIH Device Record Key | af3ce190-6166-4a78-bdb2-5a9a4db46988 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iFuse INTRA Keystone Instrument Kit |
| Version Model Number | 1029 |
| Catalog Number | 1029 |
| 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 | 00850078396136 [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 | 2025-12-25 |
| Device Publish Date | 2025-12-17 |
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