EXPRESS 139-08-0808-S

GUDID 03700879502298

Express Compressive staple 08-08-08

NOVASTEP

Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting

• Primary Device ID: 03700879502298
• NIH Device Record Key: bd10d1a7-4bce-4054-9931-3de7a41d9bf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPRESS
• Version Model Number: 139-08-0808-S
• Catalog Number: 139-08-0808-S
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	03700879502298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142111

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-02-22

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