Primary Device ID | 00853114006006 |
NIH Device Record Key | 1c94223a-2999-4532-8cb7-c538762976c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Control 360 |
Version Model Number | SK12 |
Company DUNS | 054808082 |
Company Name | TREACE MEDICAL CONCEPTS, 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 | true |
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 | 00853114006006 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-05-18 |
Device Publish Date | 2016-05-27 |
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 |
---|---|
CONTROL 360 86535501 4965818 Live/Registered |
Treace Medical Concepts, Inc. 2015-02-15 |