WoundClot Hemostatic Gauze - WoundClot hemostatic gauze is based on cellulosic - CORE SCIENTIFIC CREATIONS LTD

Duns Number:600041570

Device Description: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it fo WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding.WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.

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More Product Details

Catalog Number

101182901

Brand Name

WoundClot Hemostatic Gauze

Version/Model Number

3"X8" PreHospital FDA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K140573,K140573

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

0f41f0bd-9183-4db5-ad16-19119b5cc9aa

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

17290016339120

Quantity per Package

10

Contains DI Package

07290016339123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CORE SCIENTIFIC CREATIONS LTD" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 17