ARCAD CS041416

GUDID 03700879501284

ARCAD Compressive staple 18-14-16

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: 03700879501284
• NIH Device Record Key: bb9a1db7-4a4e-4332-8638-24eff1c960a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCAD
• Version Model Number: CS041416
• Catalog Number: CS041416
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: false
• 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	03700879501284 [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: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2015-10-16

On-Brand Devices [ARCAD]

• 03700879501918: ARCAD Compressive staple 18-18-18
• 03700879501314: ARCAD Compressive staple 25-20-20
• 03700879501307: ARCAD Compressive staple 20-18-18
• 03700879501291: ARCAD Compressive staple 18-16-18
• 03700879501284: ARCAD Compressive staple 18-14-16
• 03700879501277: ARCAD Compressive staple 18-14-14
• 03700879501260: ARCAD Compressive staple 18-12-12
• 03700879501253: ARCAD Compressive staples 15-14-14
• 03700879501246: ARCAD Compressive staple 15-12-12
• 03700879501239: ARCAD Compressive staple 08-08-08
• 03700879500416: ARCAD Compressive staple 10-15-18
• 03700879500409: ARCAD Compressive staple 10-14-16
• 03700879500393: ARCAD Compressive staple 10-12-14
• 03700879500386: ARCAD Compressive staple 10-09-09
• 03700879504148: Arcad Drill Bit Ø3 single-use
• 03700879502991: Arcad Drill Bit Ø2 single-use
• 03700879502816: Arcad Drill Bit Ø2
• 03700879501123: Arcad Drill Bit Ø3
• 03700879500973: Arcad Positionning pin Ø3
• 03700879500904: Arcad 25 Drill Guide
• 03700879500850: Arcad 20 Drill Guide
• 03700879500843: Arcad 18 Drill Guide
• 03700879500836: Arcad 15 Drill Guide
• 03700879500829: Arcad 08 Drill Guide
• 03700879500621: Long Drill Bit Ø2
• 03700879500508: Staples impactor
• 03700879500492: Arcad Positionning pin Ø2
• 03700879500485: Arcad 10 Drill Guide
• 03700879511542: Single Use Instrumentation Kit – Arcad 25
• 03700879511535: Single Use Instrumentation Kit – Arcad 20
• 03700879511528: Single Use Instrumentation Kit – Arcad 18
• 03700879511511: Single Use Instrumentation Kit – Arcad 15
• 03700879507927: Arcad 15-18-20-25 caddy
• 03700879505879: Arcad 20/25 caddy
• 03700879503493: Arcad 8/10/15/18 caddy
• 03700879500782: Staples caddy
• 03700879501949: Arcad Module
• 03700879501055: Arcad 25 forceps
• 03700879501048: Arcad 20 forceps
• 03700879501031: Arcad 18 forceps
• 03700879501024: Arcad 15 forceps
• 03700879501017: Arcad 08 forceps
• 03700879500614: Arcad 10 forceps