Primary Device ID | 00810111220613 |
NIH Device Record Key | 0db8dfd4-b550-4d09-b147-da9859a9e0b5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Retractor |
Version Model Number | 1405-2627 |
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 | 00810111220613 [Primary] |
GAD | Retractor |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
[00810111220613]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-01 |
Device Publish Date | 2022-11-23 |
00810111222792 - Cut Guide | 2024-04-19 STEPPED INLINE CUT GUIDE, SMALL |
00810111222808 - Cut Guide | 2024-04-19 STEPPED INLINE CUT GUIDE, MEDIUM |
00810111222815 - Cut Guide | 2024-04-19 STEPPED INLINE CUT GUIDE, LARGE |
00810111222723 - TMC PSI Cut Guide System | 2024-03-19 Cut Guide |
00810111222730 - TMC PSI Cut Guide System | 2024-03-19 Cut Guide |
00810111222396 - Lapiplasty SpeedPlate | 2024-02-22 Rapid Compression Implants |
00810111221849 - Derotation Pin Guide | 2024-02-13 Derotation Pin Guide |
00810111222013 - Instrument Tray | 2024-01-30 Instrument Tray |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RETRACTOR 98108925 not registered Live/Pending |
LF, LLC 2023-07-31 |
RETRACTOR 78594368 3202770 Dead/Cancelled |
Euro-Pro Operating LLC 2005-03-24 |
RETRACTOR 78525028 3134190 Dead/Cancelled |
Euro-Pro Operating LLC 2004-12-01 |
RETRACTOR 75630718 2515707 Live/Registered |
Energy Absorption Systems, Inc. 1999-01-29 |
RETRACTOR 75628877 2367962 Live/Registered |
Sellstrom Manufacturing Company 1999-01-27 |
RETRACTOR 74201204 1729400 Live/Registered |
SE-KURE CONTROLS INC. 1991-09-06 |
RETRACTOR 73628720 1498156 Dead/Cancelled |
RESEARCH & TRADING CORPORATION 1986-11-05 |
RETRACTOR 73613089 1544192 Dead/Cancelled |
WILKINSON SWORD LIMITED 1986-08-04 |
RETRACTOR 73488367 not registered Dead/Abandoned |
WILKINSON SWORD LIMITED 1984-07-05 |