Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

FDES105B

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

Yes

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

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

fee33b3a-55b8-447b-84e3-9b20cac7e009

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

10311917178674

Quantity per Package

24

Contains DI Package

00311917178677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case