Primary Device ID | 00810111224468 |
NIH Device Record Key | 7ef1b08a-24f9-4623-b2fd-aa9030f8d74c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Corner Chisel |
Version Model Number | 02-00327 |
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 | 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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810111224468 [Primary] |
FZO | Chisel, Surgical, Manual |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
[00810111224468]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-02 |
Device Publish Date | 2025-03-25 |
00810111222952 - Instrument Tray | 2025-07-24 Instrument Tray |
00810111223942 - MIS Beveled Screw | 2025-07-24 Beveled Screw |
00810111223959 - MIS Beveled Screw | 2025-07-24 Beveled Screw |
00810111223966 - MIS Beveled Screw | 2025-07-24 Beveled Screw |
00810111223973 - MIS Beveled Screw | 2025-07-24 Beveled Screw |
00810111223980 - MIS Beveled Screw | 2025-07-24 Beveled Screw |
00810111224390 - Reamer | 2025-07-24 cone reamer |
00810111222143 - Drill Guide | 2025-07-09 Drill Guide and Template |