0211130401

GUDID H67902111304010

1.25MM KIRSCHNER WIRE WITH TROCAR TIP/80MM

Synthes GmbH

Orthopaedic bone wire
Primary Device IDH67902111304010
NIH Device Record Keyb1ecc124-4366-4647-a443-725c99116dac
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.111.304.01
Catalog Number0211130401
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982031624 [Primary]
HIBCCH67902111304010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


[H67902111304010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-28
Device Publish Date2019-02-21

Devices Manufactured by Synthes GmbH

10886982350435 - NA2026-02-19 HALF BENNETT SMALL/LEFT
10886982350442 - NA2026-02-19 HALF BENNETT SMALL/RIGHT
10886982350459 - NA2026-02-19 HALF BENNETT LARGE/LEFT
10886982350466 - NA2026-02-19 HALF BENNETT LARGE/RIGHT
10886982351579 - NA2026-02-19 SHOULDER HOOK 2.2 MM TIP / 235 MM LENGTH
10886982351661 - NA2026-02-19 T-HANDLE AO CONNECTOR
10886982351678 - NA2026-02-19 T-HANDLE LARGE AO CONNECTOR
10886982361288 - NA2026-02-19 5MM AWL, QC

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