Catalog Number

0289

Brand Name

QuikClot

Version/Model Number

0289

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K072474,K072474

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

c2a81d75-8989-458f-bbaa-ae8e74bd3381

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

June 01, 2018

Package DI Number

50841495102894

Quantity per Package

50

Contains DI Package

00841495102899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper