Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302295-000-032

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

K933803,K933803

Product Code

GXY

Product Code Name

Electrode, cutaneous

Public Device Record Key

589c64d1-6157-4d8c-90c3-9f3c6be5aba3

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Package DI Number

00840067103913

Quantity per Package

24

Contains DI Package

00840067103906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box