03304322S

GUDID H67903304322S0

LOW-PROFILE WRIST FIXATOR KIT 220MM ROD/SLF-DRLG-STERILE

Synthes GmbH

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Primary Device IDH67903304322S0
NIH Device Record Key15523c69-db5a-4da0-a66c-598fc1a179f1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.304.322S
Catalog Number03304322S
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982077660 [Primary]
HIBCCH67903304322S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


[H67903304322S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-04-28
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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