QuikClot - QuikClot Hemostatic Dressing 2x2 ,CE,Multi-lang10x - Z-MEDICA, LLC

Duns Number:079190073

Device Description: QuikClot Hemostatic Dressing 2x2 ,CE,Multi-lang10x

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More Product Details

Catalog Number

0302

Brand Name

QuikClot

Version/Model Number

0302

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

25a0d6b1-a742-4783-a737-033f6b950569

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

June 01, 2018

Additional Identifiers

Package DI Number

50841495103020

Quantity per Package

24

Contains DI Package

30841495103026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"Z-MEDICA, LLC" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 27