Catalog Number

Art.- No. 642.74

Brand Name

InnoHaus

Version/Model Number

AEM44

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

b54d7939-e01f-4189-9092-f77a3270f993

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 10, 2018

Package DI Number

20853879007816

Quantity per Package

6

Contains DI Package

10853879007819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack