Primary Device ID | 00810111223737 |
NIH Device Record Key | 50ca2306-e288-4aaf-8f50-d4d4786037de |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpeedPlate - SpeedAkin |
Version Model Number | 02-00253 |
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 | false |
Device Combination Product | false |
Single Use | true |
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 | 00810111223737 [Primary] |
JDR | Staple, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
[00810111223737]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-04 |
Device Publish Date | 2025-01-27 |
00810111223737 | Inserter Rod |
00810111223683 | Inserter Cap |