VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Base 42-890-1

GUDID 07640172551936

VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Base

icotec AG

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID07640172551936
NIH Device Record Key284074bd-0be4-424b-8b6b-c304ffce477e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, VADER Pedicle System Rod-2-size, Container Base
Version Model Number42-890-1
Catalog Number42-890-1
Company DUNS480789465
Company Nameicotec AG
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+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172551936 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


[07640172551936]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-04
Device Publish Date2023-01-13

Devices Manufactured by icotec AG

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07640164846804 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm
07640164846880 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm
07640164848785 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm
07640164848792 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm
07640164848808 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm
07640164848815 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm
07640164848822 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm

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