60164002

GUDID 07612334227195

ACETABULUM TRAY FOR SIZING TRIALS AND PL INSERTION INSTR

Synthes GmbH

Surgical instrument/implant rack
Primary Device ID07612334227195
NIH Device Record Keyff2ac2d1-1575-4499-8388-98c70dda8125
Commercial Distribution StatusIn Commercial Distribution
Version Model Number60.164.002
Catalog Number60164002
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107612334227195 [Direct Marking]
GS110886982311269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


[07612334227195]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-07

Devices Manufactured by Synthes GmbH

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10886982349101 - NA2025-03-06 PLATE HOLDING FORCEPS RIGHT FLARED TIPS
10886982348265 - NA2025-03-05 XL IM REDUCTION TOOL CURVED WITH AO REAMER COUPLING
10887587078427 - NA2025-02-28 1.85MM ORTHOGNATHIC TAP
10886982344410 - NA2025-02-26 MAXFRAME CONTROL BOX TEMPLATE
10886982348333 - NA2025-02-26 1.1MM PARALLEL WIRE GUIDE
10886982348364 - NA2025-02-26 1.4MM PARALLEL WIRE GUIDE
10886982348395 - NA2025-02-26 1.6MM PARALLEL WIRE GUIDE

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