Catalog Number

-

Brand Name

Cadwell Disposable Double Ball-Tip Probe

Version/Model Number

302431-000-030

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

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

b73675b0-971f-4542-9a12-d8bd267d9a87

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

February 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-