VADER Pedicle System, Revision Sleeve 42-441

GUDID 07640172551424

VADER Pedicle System, Revision Sleeve

icotec AG

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable
Primary Device ID07640172551424
NIH Device Record Keye0716acb-6805-44be-9934-7db78dab8ef5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, Revision Sleeve
Version Model Number42-441
Catalog Number42-441
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172551424 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


[07640172551424]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-14
Device Publish Date2021-09-06

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07640140430355 - icotec Lumbar Cage ETurn TLIF 13 x 12 mm2024-03-06 icotec Lumbar Cage ETurn TLIF 13 x 12 mm
07640140430362 - icotec Lumbar Cage ETurn TLIF 15 x 12 mm2024-03-06 icotec Lumbar Cage ETurn TLIF 15 x 12 mm
07640140430379 - icotec Lumbar Cage ETurn TLIF 07 x 16 mm2024-03-06 icotec Lumbar Cage ETurn TLIF 07 x 16 mm
07640140430386 - icotec Lumbar Cage ETurn TLIF 09 x 16 mm2024-03-06 icotec Lumbar Cage ETurn TLIF 09 x 16 mm

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