TMC 3.0mm Long Screw Pack

GUDID 00853114006150

Locking Screws

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00853114006150
NIH Device Record Key96c32690-95b2-4b97-9624-feb8960b6007
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMC 3.0mm Long Screw Pack
Version Model NumberSD17
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
GS100853114006150 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-18
Device Publish Date2019-06-10

Devices Manufactured by TREACE MEDICAL CONCEPTS, INC.

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