VADER Pedicle System, Fixation device 42-893

GUDID 07640172551974

VADER Pedicle System, Fixation device

icotec AG

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• Primary Device ID: 07640172551974
• NIH Device Record Key: 61414968-4b6e-4918-a2f7-5559439bcae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VADER Pedicle System, Fixation device
• Version Model Number: 42-893
• Catalog Number: 42-893
• Company DUNS: 480789465
• Company Name: icotec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640172551974 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

[07640172551974]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-27
• Device Publish Date: 2023-01-13

Devices Manufactured by icotec AG

• 07640164846675 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm: 2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm
• 07640164846804 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm: 2024-04-04 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 mm: 2024-04-04 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 mm: 2024-04-04 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 mm: 2024-04-04 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 mm: 2024-04-04 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 mm: 2024-04-04 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 mm: 2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm