Catalog Number

5702549

Brand Name

Henry Schein

Version/Model Number

5702549

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

7db2c18f-9b19-49c2-9637-ae0da83dc662

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Package DI Number

20304040145207

Quantity per Package

20

Contains DI Package

10304040145200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case