Catalog Number

0538

Brand Name

QuikClot

Version/Model Number

0538

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072474,K072474

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

48206269-de5c-4ebc-9ca6-8df0d76664d5

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

February 09, 2021

Package DI Number

50841495105383

Quantity per Package

50

Contains DI Package

00841495105388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper