Catalog Number

0633

Brand Name

QuikClot

Version/Model Number

0633

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

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

89e91d88-1aa2-4bbc-926d-a2bb3f206f9a

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

June 01, 2018

Package DI Number

50841495106335

Quantity per Package

1

Contains DI Package

30841495106331

Package Discontinue Date

February 13, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper