QuiCover - The Zeolite Hemostatic Gauze consists of zeolite - Hangzhou Zeo-Innov Life Technology Co., Ltd.

Duns Number:541290694

Device Description: The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is pr The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.

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More Product Details

Catalog Number

-

Brand Name

QuiCover

Version/Model Number

P0910122

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

K211570,K211570,K211570,K211570

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

0d6b7e68-be45-43dc-8e9b-ce0bfc6f3caf

Public Version Date

June 15, 2022

Public Version Number

1

DI Record Publish Date

June 07, 2022

Additional Identifiers

Package DI Number

06972060310235

Quantity per Package

10

Contains DI Package

06972060310174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box