Catalog Number

10230

Brand Name

Cefaly®

Version/Model Number

Prevent

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160237,K160237

Product Code

PCC

Product Code Name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Public Device Record Key

c64df6ad-231d-4f35-a861-483e1ea48e8d

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

November 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-