Catalog Number

71002-SC/AP/12

Brand Name

9021S0235

Version/Model Number

71002-SC/AP/12

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

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

4080a2cf-86f5-4f16-af47-28972391b4fc

Public Version Date

May 27, 2020

Public Version Number

1

DI Record Publish Date

May 19, 2020

Package DI Number

05707480038220

Quantity per Package

2

Contains DI Package

05707480038237

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-