CENTROLOCK XTI06010

GUDID 03700879516011

Centrolock Stemless trial sizer Left

NOVASTEP

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03700879516011
• NIH Device Record Key: ef8cff64-9e80-41e0-8566-809290958665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTROLOCK
• Version Model Number: XTI06010
• Catalog Number: XTI06010
• Company DUNS: 264255288
• Company Name: NOVASTEP
• 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: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879516011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192356

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

[03700879516011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [CENTROLOCK]

• 03700879516028: Centrolock Stemless trial sizer Right
• 03700879516011: Centrolock Stemless trial sizer Left