Catalog Number

900

Brand Name

S&W

Version/Model Number

FS-50C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

ace9d26b-10e6-41a0-a250-82a005a21783

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2017

Package DI Number

30854661006458

Quantity per Package

4

Contains DI Package

20854661006451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case