212426

GUDID H6792124260

3.5MM CONICAL SCREW SLF-TPNG PARTIALLY THREADED 70MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH6792124260
NIH Device Record Keydf2b7564-cd7a-4b88-9bd7-a3a8982a02ef
Commercial Distribution StatusIn Commercial Distribution
Version Model Number212.426
Catalog Number212426
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
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982152701 [Primary]
HIBCCH6792124260 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

Moist Heat or Steam Sterilization


[H6792124260]

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

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07612334268563 - KINCISE2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
07612334268570 - KINCISE2024-11-04 KINCISE™ System Lithium-ion Battery
07612334268594 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
07612334268600 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
07612334268617 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide

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