Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302298-000-118

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"

-

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

96b6ccaa-4ae1-4cba-8fd7-43cb14369f5e

Public Version Date

July 03, 2020

Public Version Number

1

DI Record Publish Date

June 25, 2020

Package DI Number

08718375867662

Quantity per Package

10

Contains DI Package

08718375867679

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box