EXPRESS 139-00-0115

GUDID 03700879502113

EXPRESS Drill Guide (Staples L15 mm)

NOVASTEP

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03700879502113
• NIH Device Record Key: 30ea4274-096a-47d7-b39f-a4038f0350e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPRESS
• Version Model Number: 139-00-0115
• Catalog Number: 139-00-0115
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879502113 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

[03700879502113]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-04-15

On-Brand Devices [EXPRESS]

• 03700879512181: EXPRESS large Staple Impactor
• 03700879502205: EXPRESS Forceps (Staples L25 mm)
• 03700879502199: EXPRESS Forceps (Staples L20 mm)
• 03700879502182: EXPRESS Forceps (Staples L18 mm)
• 03700879502175: EXPRESS Forceps (Staples L15 mm)
• 03700879502168: EXPRESS Forceps (Staples L10 mm)
• 03700879502151: EXPRESS Forceps (Staples L8 mm)
• 03700879502144: EXPRESS Drill Guide (Staples L25 mm)
• 03700879502137: EXPRESS Drill Guide (Staples L20 mm)
• 03700879502120: EXPRESS Drill Guide (Staples L18 mm)
• 03700879502113: EXPRESS Drill Guide (Staples L15 mm)
• 03700879502106: EXPRESS Drill Guide (Staples L10 mm)
• 03700879502090: EXPRESS Drill Guide (Staples L8 mm)
• 03700879502083: EXPRESS Ø3mm Solid Drill
• 03700879502076: EXPRESS Ø2mm Solid Drill
• 03700879502045: EXPRESS Ø3mm Positioning Pin
• 03700879502038: EXPRESS Ø2mm Positioning Pin
• 03700879502021: EXPRESS Staple Impactor
• 03700879502366: Express Compressive staple 25-20-20
• 03700879502359: Express Compressive staple 20-18-18
• 03700879502342: Express Compressive staple 18-18-18
• 03700879502335: Express Compressive staple 18-14-14
• 03700879502328: Express Compressive staple 15-14-14
• 03700879502311: Express Compressive staple 10-12-14
• 03700879502304: Express Compressive staple 10-09-09
• 03700879502298: Express Compressive staple 08-08-08
• 03700879512204: eXpress Staple Tray - Hindfoot
• 03700879512198: eXpress Staple Tray lid
• 03700879502014: eXpress Staple Tray