04211412S

GUDID H67904211412S0

2.7MM TI VA-LOCKING ANTLAT CALCANEAL PL LONG 56MM RT-STER

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH67904211412S0
NIH Device Record Keyb293cbb4-43f6-49d3-8310-a322364ff655
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.211.412S
Catalog Number04211412S
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
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
GS110886982120441 [Primary]
HIBCCH67904211412S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

Moist Heat or Steam Sterilization


[H67904211412S0]

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

10886982348982 - NA2025-07-24 Ø12.8MM HOLLOW REAMER
10886982349835 - NA2025-07-24 WRENCH / 11MM SLOTTED SOCKET
10886982350121 - NA2025-07-24 FEMORAL GONIOMETER
10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR
10886982348326 - NA2025-07-08 SCREW RACK 3.0 & 4.0
10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN

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