| Primary Device ID | EAMIFIX20011 |
| NIH Device Record Key | 8c09fdfc-9e6d-4255-ab1d-e5072a4d1faa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FiXcision |
| Version Model Number | FIX2001 |
| Catalog Number | FIX2001 |
| Company DUNS | 303655286 |
| Company Name | AMI Agency for Medical Innovations GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
|---|---|
| HIBCC | EAMIFIX20010 [Primary] |
| HIBCC | EAMIFIX20011 [Package] Contains: EAMIFIX20010 Package: [10 Units] In Commercial Distribution |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-12 |
| Device Publish Date | 2018-12-14 |
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