02210122

GUDID H679022101220

2.4MM VA LOCKING SCREW STARDRIVE 22MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH679022101220
NIH Device Record Key064b5b6e-e8a4-4707-95b9-5723fe979d28
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.210.122
Catalog Number02210122
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
GS110886982052995 [Primary]
HIBCCH679022101220 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


[H679022101220]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10886982350039 - NA2025-08-15 CRE DRILL GUIDE 15MM
10886982350046 - NA2025-08-15 CRE DRILL GUIDE 18MM
10886982350053 - NA2025-08-15 CRE DRILL GUIDE 20MM
10886982350060 - NA2025-08-15 CRE DRILL GUIDE 25MM
10886982350077 - NA2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2

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