AccessGUDID - DEVICE: Cefaly® (05425018850280)

GUDID

Device Identifier (DI) Information

Brand Name: Cefaly®
Version or Model: CEFALY Enhanced
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10701
Company Name: Cefaly Technology SPRL

Primary DI Number: 05425018850280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 762450752 *Terms of Use

Device Description: CEFALY Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY Enhanced is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60682	Craniofacial analgesia electrical stimulator	A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212071	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 23 and 95 Degrees Fahrenheit
Storage Environment Humidity: between 45 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 50 and 95 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ead85ab2-c422-4bc5-9c2f-0271daa14a50
Public Version Date: December 30, 2022
Public Version Number: 1
DI Record Publish Date: December 22, 2022