Catalog Number

-

Brand Name

Walgreens

Version/Model Number

68-033

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

f146de1f-ec75-4301-9a4b-00b9fa5b6cbf

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2018

Package DI Number

30311917199222

Quantity per Package

3

Contains DI Package

00311917199221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton