03306001

GUDID H679033060010

OUTER RAIL FOR PELVIC C-CLAMP II

Synthes GmbH

Pelvic C-clamp
Primary Device IDH679033060010
NIH Device Record Key03d80af5-eb7a-42a5-8391-d5efba659880
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.306.001
Catalog Number03306001
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
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
GS107611819791381 [Direct Marking]
GS110886982077684 [Primary]
HIBCCH679033060010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECCOMPONENT, TRACTION, INVASIVE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

Moist Heat or Steam Sterilization


[H679033060010]

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

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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
10886982349088 - NA2025-02-26 TERMITE REDUCTION FORCEPS SERRATED JAW
H6792050550 - NA2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
H6794089050 - NA2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM

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