Catalog Number

FGS-017

Brand Name

CARDINAL HEALTH

Version/Model Number

FGS-017

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

HRQ

Product Code Name

HEMOSTAT

Public Device Record Key

6f8dd60d-cf0b-42ed-a79c-5e11b4275bda

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Package DI Number

50888439919231

Quantity per Package

50

Contains DI Package

10888439919233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE