Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302426-000

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

dd0e7ee6-aa4f-4767-8379-b831c85cfc3e

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

26955739000297

Quantity per Package

10

Contains DI Package

16955739000290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box