VADER Pedicle System, Rod inserter, for cut rods 42-899

GUDID 07640172552070

VADER Pedicle System, Rod inserter, for cut rods

icotec AG

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID07640172552070
NIH Device Record Key21e5a12f-d3f3-41a8-a41a-907db1ac28d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, Rod inserter, for cut rods
Version Model Number42-899
Catalog Number42-899
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172552070 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


[07640172552070]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2023-01-13

Devices Manufactured by icotec AG

07640172552070 - VADER Pedicle System, Rod inserter, for cut rods2024-09-11VADER Pedicle System, Rod inserter, for cut rods
07640172552070 - VADER Pedicle System, Rod inserter, for cut rods2024-09-11 VADER Pedicle System, Rod inserter, for cut rods
07640172551530 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm
07640172551547 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm
07640172551554 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm
07640172551561 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm
07640172551578 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mm
07640172551585 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mm
07640172551615 - VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mm2024-08-08 VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mm

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