Catalog Number

-

Brand Name

N/A

Version/Model Number

E100-6R

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

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

48cc50de-50ba-433e-908c-4f4c13a140f7

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

October 13, 2016

Package DI Number

00815067013173

Quantity per Package

12

Contains DI Package

10815067013132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA