Catalog Number

SC-08-VS/AP/50

Brand Name

9013L0203

Version/Model Number

SC-08-VS/AP/50

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

0e8e3235-f699-420f-bec4-c0abe2c2cb21

Public Version Date

May 27, 2020

Public Version Number

1

DI Record Publish Date

May 19, 2020

Package DI Number

05707480038107

Quantity per Package

2

Contains DI Package

05707480038114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-