Primary Device ID | 00810111224109 |
NIH Device Record Key | 1bb0a48b-ef08-4e93-9846-cad950b31072 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Evans Trial |
Version Model Number | 02-00315 |
Company DUNS | 054808082 |
Company Name | Treace Medical Concepts, Inc. |
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 | false |
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 | 00810111224109 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
[00810111224109]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-27 |
Device Publish Date | 2025-03-19 |
00810111224253 | TMC Evans Trial, 12mm |
00810111224116 | TMC Evans Trial, 10mm |
00810111224109 | TMC Evans Trial, 8mm |
00810111224093 | TMC Evans Trial, 6mm |