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 |
00810111224611 - Chisel | 2025-06-02 Corner Chisel |
00810111224246 - Elevator | 2025-05-30 MIS Elevator |
00810111224284 - Rasp | 2025-05-30 MIS Rasp |
00810111224291 - Saw Blade | 2025-05-30 Akin Saw Blade - ZMS |
00810111224574 - Gage | 2025-05-30 Length Gage |
00810111224581 - Tail Tack | 2025-05-30 Stepped Tail Tack |
00810111224680 - TMC PSI Cut Guide System | 2025-05-30 Cut Guide |
00810111224697 - TMC PSI Cut Guide System | 2025-05-30 Cut Guide |