412428

GUDID H6794124280

3.5MM TI CONICAL SCREW SLF-TPNG PARTIALLY THRDD 80MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH6794124280
NIH Device Record Key3caf250c-30d6-4138-b804-8cab804a7a8b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number412.428
Catalog Number412428
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
GS110886982211491 [Primary]
HIBCCH6794124280 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


[H6794124280]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-02
Device Publish Date2015-09-14

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