VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm 42-546-1

GUDID 07640172552902

VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm

icotec AG

Spinal intraoperative positioning pin, reusable
Primary Device ID07640172552902
NIH Device Record Key643dc712-76b6-4669-a567-0bde635b8347
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm
Version Model Number42-546-1
Catalog Number42-546-1
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+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch
Phone+417570000
Emailinfo@icotec.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172552902 [Primary]

FDA Product Code

PMLBone Cement, Posterior Screw Augmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

[07640172552902]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-02
Device Publish Date2024-11-22

Devices Manufactured by icotec AG

07640172551967 - VADER Pedicle System, Handle, 1/4" Coupling2025-08-07 VADER Pedicle System, Handle, 1/4" Coupling
07640172551981 - VADER Pedicle System, Deburring tool2025-08-07 VADER Pedicle System, Deburring tool
07640172551998 - VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm2025-08-07 VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm
07640172552001 - VADER Pedicle System, Template for HT S-rods2025-08-07 VADER Pedicle System, Template for HT S-rods
07640172552018 - VADER Pedicle System, Template for TL S-rods2025-08-07 VADER Pedicle System, Template for TL S-rods
07640172552025 - VADER Pedicle System, Template for L S-rods2025-08-07 VADER Pedicle System, Template for L S-rods
07640172552056 - VADER Pedicle System, Template for R120 & R450 curved rods2025-08-07 VADER Pedicle System, Template for R120 & R450 curved rods
07640172552063 - VADER Pedicle System, Hexagon screw driver2025-08-07 VADER Pedicle System, Hexagon screw driver
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