03306003

GUDID H679033060030

LOWER SIDE ARM FOR PELVIC C-CLAMP II

Synthes GmbH

Pelvic C-clamp
Primary Device IDH679033060030
NIH Device Record Key7b15f4c7-9545-4490-b068-5bcb0efce254
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.306.003
Catalog Number03306003
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
GS107611819791404 [Direct Marking]
GS110886982077707 [Primary]
HIBCCH679033060030 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECCOMPONENT, TRACTION, INVASIVE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

Moist Heat or Steam Sterilization


[H679033060030]

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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10886982322999 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 44MM T8 STERILE
10886982323002 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8
10886982323019 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8 STERILE
10886982323026 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8
10886982323033 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8 STERILE
10886982323040 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8
10886982323057 - VOLT2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8 STERILE

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