Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

MDTS100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

9b7af543-52fa-44d7-9ccc-15698bc4b50f

Public Version Date

July 14, 2021

Public Version Number

1

DI Record Publish Date

July 06, 2021

Package DI Number

10311917013418

Quantity per Package

48

Contains DI Package

00311917013411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case