FairFix Adjustable Button System

GUDID 07630345703927

FairFix Adjustable Button

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID07630345703927
NIH Device Record Key5a2d7c67-08be-477e-9a9c-5166c425ebc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFairFix Adjustable Button System
Version Model Number05.05.0091
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS107630345703927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-06
Device Publish Date2021-03-29

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