04221005S

GUDID H67904221005S0

5.0MM TI CRIMP POSITIONING PIN STERILE

Synthes GmbH

Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device IDH67904221005S0
NIH Device Record Keyef895eb4-8600-4832-b6f8-3747af5a30d1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.221.005S
Catalog Number04221005S
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
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
GS110886982121004 [Primary]
HIBCCH67904221005S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDQCERCLAGE, FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


[H67904221005S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

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10886982344427 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/TIBIAL FIXTN/LNG/STER
10886982344434 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/TIBIAL FIXTN/LNG/STER
10886982345745 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/LONG/STERILE
10886982345752 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/LONG/STERILE
H67904038070S0 - TFN-ADVANCE2024-02-27 TFNA SCREW 70MM - STERILE
H6792161400 - NA2024-02-27 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/140MM
H6792180750 - NA2024-02-27 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/75MM

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