Catalog Number

0458

Brand Name

QuikClot

Version/Model Number

0458

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123387,K123387,K123387

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

9d113551-a1ac-443c-9fe6-26a7d1868782

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

September 27, 2017

Package DI Number

30841495104580

Quantity per Package

10

Contains DI Package

00841495104589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON