nexis® XRE01008D

GUDID 03700879512105

Ø4.9 counterboring single-use

NOVASTEP

Cannulated surgical drill bit, single-use

• Primary Device ID: 03700879512105
• NIH Device Record Key: 28d425f4-850f-4a02-be7f-3d9f016d3a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nexis®
• Version Model Number: XRE01008D
• Catalog Number: XRE01008D
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879512105 [Primary]

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

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

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

[03700879512105]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

Devices Manufactured by NOVASTEP

• 03700879517445 - NA: 2024-09-20 K-wire Ø1.8 Lg 140 TR/RD - sterile
• 03700879517452 - Tarsoplasty®: 2024-09-20 Threaded k-wire Ø1.8 Lg 70 TR/RD - sterile
• 03700879516479 - arcad® 2.0: 2024-08-16 Akin Compressive staple Duo 10x10x12
• 03700879517414 - NA: 2024-08-15 K-wire Ø1.8 Lg 140 TR/RD
• 03700879517421 - NA: 2024-08-15 Threaded k-wire Ø1.8 Lg 70 TR/RD
• 03700879517438 - Tarsoplasty®: 2024-08-15 Locking wheel
• 03700879516486 - arcad® 2.0: 2024-04-24 Compressive staple Duo 12x12
• 03700879516493 - arcad® 2.0: 2024-04-24 Compressive staple Duo 15x15