Catalog Number

-

Brand Name

Cadwell Twisted Disposable Subdermal Needle Electrode

Version/Model Number

302820-000-080

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

-

Product Code

GXZ

Product Code Name

ELECTRODE, NEEDLE

Public Device Record Key

d254a64f-f6c7-409f-94e4-4731aa4b71cc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 05, 2016

Package DI Number

10840067101282

Quantity per Package

12

Contains DI Package

00840067101285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box