VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm 42-597

GUDID 07640172553572

VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm

icotec AG

Surgical screwdriver, reusable
Primary Device ID07640172553572
NIH Device Record Key28ff2199-68f1-489b-b1eb-6a7fbd612e66
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm
Version Model Number42-597
Catalog Number42-597
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 Batchfalse
Serial Numbertrue
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
Phone+41717570000
Emailinfo@icotec.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172553572 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


[07640172553572]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-13
Device Publish Date2025-03-05

Devices Manufactured by icotec AG

07640172552858 - VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm2025-03-13 VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm
07640172552865 - VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm2025-03-13 VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm
07640172552872 - icotec Systems, Torque-Limiting Adapter, 3.5 Nm2025-03-13 icotec Systems, Torque-Limiting Adapter, 3.5 Nm
07640172552889 - VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm2025-03-13 VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm
07640172553572 - VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm2025-03-13VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm
07640172553572 - VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm2025-03-13 VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm
07640172552896 - VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 2024-12-02 VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600
07640172552902 - VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm2024-12-02 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm
07640172552919 - VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm2024-12-02 VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.