| Primary Device ID | M364110204FD20 |
| NIH Device Record Key | 2137e366-aaab-45bc-944b-81b731c6139c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dakota Knife Blade® |
| Version Model Number | 11-0204-FD2 |
| Catalog Number | 11-0204-FD2 |
| Company DUNS | 003815548 |
| Company Name | MEDICAL DESIGNS LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | 1102042 [Direct Marking] |
| HIBCC | M364110204FD20 [Primary] |
| GDZ | Handle, Scalpel |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-11-06 |
| Device Publish Date | 2016-09-27 |
| M364111106FD1200 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 20mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106122 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 22mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106124 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 24mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106126 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 26mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106128 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 28mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106130 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 30mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106132 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |
| 111106134 - Asfora Anterior Cervical Plate System | 2023-09-18 1 Level, 34mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the an |