Catalog Number

-

Brand Name

Beurer

Version/Model Number

EM44

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"

Yes

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

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

c3e3e071-9dae-4d25-a16d-2b345cbedb25

Public Version Date

February 19, 2021

Public Version Number

9

DI Record Publish Date

August 28, 2017

Package DI Number

20853879007281

Quantity per Package

6

Contains DI Package

10853879007284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case