03632322

GUDID 07611819588837

PEDICLE ACCESS CANNULA SHAFT

SYNTHES (U.S.A.) LP

Orthopaedic implant/trial-implant/sizer holder, reusable
Primary Device ID07611819588837
NIH Device Record Key17c5e2d1-5a21-4a06-bb9c-cbc403abed15
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.632.322
Catalog Number03632322
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819588837 [Direct Marking]
GS110705034719801 [Primary]
HIBCCH981036323220 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


[07611819588837]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-06
Device Publish Date2016-06-30

Devices Manufactured by SYNTHES (U.S.A.) LP

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H9812982060 - NA2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
H6792042280 - NA2024-07-24 3.5MM SHAFT SCREW 28MM
H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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