| Primary Device ID | 00817577022294 |
| NIH Device Record Key | f014b489-e328-45e2-997f-8b357c4cedc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EPIC FOOT PLATE SYSTEM |
| Version Model Number | B |
| Catalog Number | 2000-4000 |
| Company DUNS | 157565946 |
| Company Name | Exactech, Inc. |
| 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 | false |
| Expiration Date | false |
| 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 | 00817577022294 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817577022294]
Moist Heat or Steam Sterilization
[00817577022294]
Moist Heat or Steam Sterilization
[00817577022294]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-30 |
| Device Publish Date | 2016-09-24 |