Catalog Number

10405

Brand Name

Cefaly®

Version/Model Number

Acute

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

K171446

Product Code

PCC

Product Code Name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Public Device Record Key

9955f733-00c0-4f9a-a646-afc97d5565b5

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

-