Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302825-000-060

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

K072276,K072276

Product Code

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

10e14792-60f8-41f2-80e0-94e9a56d1a08

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2018

Package DI Number

26955739013198

Quantity per Package

24

Contains DI Package

16955739013191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box