Cefaly®

GUDID 05425018850143

Kit 3 electrodes for Cefaly II

Cefaly Technology SPRL

Craniofacial analgesia electrical stimulator
Primary Device ID05425018850143
NIH Device Record Key35ade0b4-0661-4f60-8e6b-729832ee832d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCefaly®
Version Model Number11201
Company DUNS762450752
Company NameCefaly Technology SPRL
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(203) 309-5670
Emailinfo@cefaly.us

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425018850143 [Primary]
GS105425018850174 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2016-09-17

On-Brand Devices [Cefaly®]

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

Trademark Results [Cefaly]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CEFALY
CEFALY
87924056 not registered Live/Pending
CEFALY Technology
2018-05-16
CEFALY
CEFALY
79053734 3647710 Live/Registered
CEFALY Technology
2008-04-28

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