Catalog Number

-

Brand Name

Cadwell Disposable Monopolar Probe

Version/Model Number

302400-000

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

K103128

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

0f590f6d-a1a9-4067-b349-b385760159f5

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-