Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302421-000

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112426,K112426

Product Code

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

8748c630-8e43-4b7d-bf47-dadedeac97a1

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

26955739000259

Quantity per Package

1

Contains DI Package

16955739000252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box