Alpha ACLS-049-S16

GUDID 00194711116164

Alpha Control Liner System Kit Small, 16 cm Leads

Willowwood Global LLC

Analytical non-scalp cutaneous electrode

• Primary Device ID: 00194711116164
• NIH Device Record Key: a24c797c-2c2e-4382-aed2-4d3f3b67b13c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpha
• Version Model Number: ACLS-049-S16
• Catalog Number: ACLS-049-S16
• Company DUNS: 004280723
• Company Name: Willowwood Global LLC
• 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: false
• Serial Number: true
• 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: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx
• Phone: 800-848-4930
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00194711116164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223738

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Alpha]

• 00194711116201: Alpha Control Liner System Kit Medium, 4 cm Leads
• 00194711116676: Alpha Control Fitting Liner, Medium
• 00194711116669: Alpha Control Fitting Liner, Small
• 00194711116652: Alpha Control Fitting Liner, Extra Small
• 00194711116645: Alpha Control Liner Fabrication Dummy Kit
• 00194711116638: Alpha Control Liner Cap
• 00194711116621: Alpha Control Module
• 00194711116614: Alpha Control Liner Lock (Button)
• 00194711116607: Alpha Control Liner Electrode
• 00194711116591: Alpha Control Liner Medium, 22 cm Leads
• 00194711116584: Alpha Control Liner Medium, 20 cm Leads
• 00194711116577: Alpha Control Liner Medium, 18 cm Leads
• 00194711116560: Alpha Control Liner Medium, 16 cm Leads
• 00194711116553: Alpha Control Liner Medium, 14 cm Leads
• 00194711116546: Alpha Control Liner Medium, 12 cm Leads
• 00194711116539: Alpha Control Liner Medium, 10 cm Leads
• 00194711116522: Alpha Control Liner Medium, 8 cm Leads
• 00194711116515: Alpha Control Liner Medium, 6 cm Leads
• 00194711116508: Alpha Control Liner Medium, 4 cm Leads
• 00194711116492: Alpha Control Liner Small, 22 cm Leads
• 00194711116485: Alpha Control Liner Small, 20 cm Leads
• 00194711116478: Alpha Control Liner Small, 18 cm Leads
• 00194711116461: Alpha Control Liner Small, 16 cm Leads
• 00194711116454: Alpha Control Liner Small, 14 cm Leads
• 00194711116447: Alpha Control Liner Small, 12 cm Leads
• 00194711116430: Alpha Control Liner Small, 10 cm Leads
• 00194711116423: Alpha Control Liner Small, 8 cm Leads
• 00194711116416: Alpha Control Liner Small, 6 cm Leads
• 00194711116409: Alpha Control Liner Small, 4 cm Leads
• 00194711116393: Alpha Control Liner Extra Small, 22 cm Leads
• 00194711116386: Alpha Control Liner Extra Small, 20 cm Leads
• 00194711116379: Alpha Control Liner Extra Small, 18 cm Leads
• 00194711116362: Alpha Control Liner Extra Small, 16 cm Leads
• 00194711116355: Alpha Control Liner Extra Small, 14 cm Leads
• 00194711116348: Alpha Control Liner Extra Small, 12 cm Leads
• 00194711116331: Alpha Control Liner Extra Small, 10 cm Leads
• 00194711116324: Alpha Control Liner Extra Small, 8 cm Leads
• 00194711116317: Alpha Control Liner Extra Small, 6 cm Leads
• 00194711116300: Alpha Control Liner Extra Small, 4 cm Leads
• 00194711116294: Alpha Control Liner System Kit Medium, 22 cm Leads
• 00194711116287: Alpha Control Liner System Kit Medium, 20 cm Leads
• 00194711116270: Alpha Control Liner System Kit Medium, 18 cm Leads
• 00194711116263: Alpha Control Liner System Kit Medium, 16 cm Leads
• 00194711116256: Alpha Control Liner System Kit Medium, 14 cm Leads
• 00194711116249: Alpha Control Liner System Kit Medium, 12 cm Leads
• 00194711116232: Alpha Control Liner System Kit Medium, 10 cm Leads
• 00194711116225: Alpha Control Liner System Kit Medium, 8 cm Leads
• 00194711116218: Alpha Control Liner System Kit Medium, 6 cm Leads
• 00194711116195: Alpha Control Liner System Kit Small, 22 cm Leads
• 00194711116188: Alpha Control Liner System Kit Small, 20 cm Leads