Arcus

GUDID 00190376240268

Arcus Guided Access System - Diamond Tip, Sterile

ALPHATEC SPINE, INC.

Neurophysiologic monitoring system

• Primary Device ID: 00190376240268
• NIH Device Record Key: 60ab9c34-fa38-4b12-8141-7c400dc41c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arcus
• Version Model Number: 16122-01-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• 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: true
• 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: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376240268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191723

FDA Product Code

• PDQ: Neurosurgical nerve locator

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: 2021-03-03
• Device Publish Date: 2021-02-23

On-Brand Devices [Arcus]

• 00190376215884: Arcus Stimulating Targeting Needle, Bevel Tip
• 00190376215877: Arcus Stimulating Targeting Needle, Diamond Tip
• 00190376240275: Arcus Guided Access System - Bevel Tip, Sterile
• 00190376240268: Arcus Guided Access System - Diamond Tip, Sterile
• 00190376309484: Arcus Home-Base Clip