Catalog Number

-

Brand Name

Welby

Version/Model Number

TEN603

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

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

de5c3b0c-e9d3-422a-97a0-4393d4177195

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

June 04, 2018

Package DI Number

16926408710314

Quantity per Package

4

Contains DI Package

06926408710317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-