TMC SpeedMTP

GUDID 00810111223492

Rapid Compression Implants

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable
Primary Device ID00810111223492
NIH Device Record Key3582ab24-c21a-4725-9285-7c3f32d7fd4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMC SpeedMTP
Version Model NumberSK59
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111223492 [Primary]

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-26
Device Publish Date2024-11-18

On-Brand Devices [TMC SpeedMTP]

00810111223669Inserter Cap
00810111223652Inserter Cap
00810111223508Rapid Compression Implants
00810111223492Rapid Compression Implants
00810111223485Locking Screws

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.