Catalog Number

-

Brand Name

Cefaly®

Version/Model Number

11302

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PCC

Product Code Name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Public Device Record Key

c46172c3-62e0-4a5b-b820-b5499ef5ee74

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-