SpeedPlate - SpeedAkin

GUDID 00810111223683

Inserter Cap

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable
Primary Device ID00810111223683
NIH Device Record Keya92fa8ac-a423-4eac-bff2-af4346c0d29f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeedPlate - SpeedAkin
Version Model Number02-00254
Company DUNS054808082
Company NameTreace Medical Concepts, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111223683 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


[00810111223683]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-04
Device Publish Date2025-01-27

On-Brand Devices [SpeedPlate - SpeedAkin]

00810111223737Inserter Rod
00810111223683Inserter Cap

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