CENTROLOCK XTI06010

GUDID 03700879516011

Centrolock Stemless trial sizer Left

NOVASTEP

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• 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