Plantar Python 2 Left

GUDID 00853114006082

Anatomic Tension Side Plate

TREACE MEDICAL CONCEPTS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID00853114006082
NIH Device Record Key6b726d62-e08e-43b6-9570-2eca178862c0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlantar Python 2 Left
Version Model NumberSD14
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
GS100853114006082 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-18
Device Publish Date2018-05-17

Devices Manufactured by TREACE MEDICAL CONCEPTS, INC.

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