Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302360-000-060

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

c43f4f62-e8db-4b9b-963c-3da3aa54ce70

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2018

Package DI Number

26955739013297

Quantity per Package

12

Contains DI Package

16955739013290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box