406436

GUDID H6794064360

4.0MM TI CORTEX SCREW SELF-TAPPING/36MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH6794064360
NIH Device Record Keyb9435bd6-9b66-4c87-8960-5f8f993cf6fe
Commercial Distribution StatusIn Commercial Distribution
Version Model Number406.436
Catalog Number406436
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
GS110886982207821 [Primary]
HIBCCH6794064360 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

Moist Heat or Steam Sterilization


[H6794064360]

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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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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