arcad® 2.0 CSK202020

GUDID 03700879516516

Compressive staple Duo 20x20

NOVASTEP

Surgical staple loading unit, non-cutting

• Primary Device ID: 03700879516516
• NIH Device Record Key: 61b26be6-1532-48e8-a8a4-35793a1c29c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: arcad® 2.0
• Version Model Number: CSK202020
• Catalog Number: CSK202020
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879516516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230724

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [arcad® 2.0]

• 03700879516585: Extraction forceps
• 03700879516561: Trial Sizer
• 03700879516554: MTP Compressive staple Quadro 30x16x16x14x12
• 03700879516547: Compressive staple Quadro 30x20
• 03700879516530: Compressive staple Quadro 26x18
• 03700879516523: Compressive staple Duo 25x20
• 03700879516516: Compressive staple Duo 20x20
• 03700879516509: Compressive staple Duo 18x18
• 03700879516493: Compressive staple Duo 15x15
• 03700879516486: Compressive staple Duo 12x12
• 03700879516479: Akin Compressive staple Duo 10x10x12