XMS01054

GUDID 03700879518190

Translation tool

NOVASTEP

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03700879518190
• NIH Device Record Key: 0978c675-3b58-40bd-830b-5e925581e57d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: XMS01054
• Catalog Number: XMS01054
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879518190 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

[03700879518190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

Devices Manufactured by NOVASTEP

• 03700879517940 - PECA®2.0: 2025-11-21 Tray
• 03700879517957 - PECA®2.0: 2025-11-21 Lid
• 03700879518039 - NA: 2025-09-30 Threaded shouldered pin Ø2.5 lg 72
• 03700879518046 - NA: 2025-09-30 Threaded shouldered pin Ø2.5 lg 72 - sterile
• 03700879518138 - NA: 2025-09-30 Cutting guide frame
• 03700879518145 - NA: 2025-09-30 Calca slide centering window
• 03700879518169 - NA: 2025-09-30 Calca slide cutting window
• 03700879518190 - NA: 2025-09-30Translation tool
• 03700879518190 - NA: 2025-09-30 Translation tool