Cefaly®

GUDID 05425018850143

Kit 3 electrodes for Cefaly II

Cefaly Technology SPRL

Craniofacial analgesia electrical stimulator

• Primary Device ID: 05425018850143
• NIH Device Record Key: 35ade0b4-0661-4f60-8e6b-729832ee832d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cefaly®
• Version Model Number: 11201
• Company DUNS: 762450752
• Company Name: Cefaly Technology SPRL
• Device Count: 3
• 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: false
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (203) 309-5670
• Email: info@cefaly.us

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425018850143 [Primary]
GS1	05425018850174 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160237

FDA Product Code

• PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-09-17

On-Brand Devices [Cefaly®]

• 05425018850129: The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in
• 05425018850259: The Cefaly® Dual device is indicated for: - The acute treatment of migraine with or without aur
• 05425018850242: The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura
• 05425018850150: Kit 3 Electrodes Blue Gel for Cefaly II
• 05425018850143: Kit 3 electrodes for Cefaly II
• 05425018850105: Kit 3 electrodes Blue Gel for Cefaly I
• 05425018850044: Kit 3 electrodes for Cefaly I
• 05425018850273: Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indicat
• 05425018850181: Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)
• 05425018850174: CEFALY Enhanced Electrode Kit .3 electrodes