03000160S

GUDID H67903000160S0

SWANSON BURR S Ø 5.0MM HEAD LENGTH 15.8MM

Synthes GmbH

Orthopaedic bur, reusable
Primary Device IDH67903000160S0
NIH Device Record Keyd7d70dd0-802c-4bed-adb8-98c47be1a00a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.000.160S
Catalog Number03000160S
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
GS110886982065131 [Primary]
HIBCCH67903000160S0 [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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10886982348364 - NA2025-02-26 1.4MM PARALLEL WIRE GUIDE
10886982348395 - NA2025-02-26 1.6MM PARALLEL WIRE GUIDE
10886982349088 - NA2025-02-26 TERMITE REDUCTION FORCEPS SERRATED JAW
H6792050550 - NA2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
H6794089050 - NA2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM

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