03000121S

GUDID H67903000121S0

SWANSON BURR S Ø 4.0MM HEAD LENGTH 12.7MM

Synthes GmbH

Orthopaedic bur, reusable
Primary Device IDH67903000121S0
NIH Device Record Key9f425868-cf0e-4249-af78-add12bb33dfe
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.000.121S
Catalog Number03000121S
Company DUNS486711679
Company NameSynthes GmbH
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

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982065049 [Primary]
HIBCCH67903000121S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-18
Device Publish Date2016-06-30

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07612334292100 - NA2024-08-02 TRAY FOR REDUCTION AND SCREW INSERTION INSTRUMENTS
07612334292117 - NA2024-08-02 TRAY FOR LCP PLATES
07612334292124 - NA2024-08-02 SCREW CADDY
07612334292131 - NA2024-08-02 TRAY F/WIRE IMPL & INSTRUMENTS
10886982347466 - NA2024-08-02 RIGID INSERTION SLEEVE

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