03028011

GUDID 07612334119056

EASY LOADER W/ AO QC FOR QUICK INSERTION SCREWS

Synthes GmbH

Screwing power tool attachment
Primary Device ID07612334119056
NIH Device Record Key3ce38522-99ad-4507-884e-16e515339e8a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.028.011
Catalog Number03028011
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107612334119056 [Direct Marking]
GS110886982273017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


[07612334119056]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-29
Device Publish Date2019-10-05

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10886982350190 - NA2025-09-22 2.0MM STRAIGHT PLATE 20 HOLES
10887587078465 - NA2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
10886982349873 - NA2025-09-01 CANNULATED CIRCULAR REAMER 16MM
10886982349880 - NA2025-09-01 CANNULATED CIRCULAR REAMER 18MM
10886982349897 - NA2025-09-01 CANNULATED CIRCULAR REAMER 20MM
10886982349903 - NA2025-09-01 CANNULATED CIRCULAR REAMER 22MM

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