QuiCover

GUDID 06972060310464

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 availiable in a range of different sizes.

Hangzhou Zeo-Innov Life Technology Co., Ltd.

Non-organic haemostatic agent

• Primary Device ID: 06972060310464
• NIH Device Record Key: fae137b9-4fe3-425e-9046-7ef081b4e7c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuiCover
• Version Model Number: P-9cm×10cm-12,2 pieces/bag
• Company DUNS: 541290694
• Company Name: Hangzhou Zeo-Innov Life Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972060310457 [Primary]
GS1	06972060310464 [Package]; Contains: 06972060310457; Package: box [10 Units]; In Commercial Distribution
GS1	06972060310471 [Package]; Package: case [10 Units]; In Commercial Distribution
GS1	06972060310488 [Package]; Contains: 06972060310471; Package: carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211570

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [QuiCover]

• 06972060310235: The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided
• 06972060310464: The Zeolite Hemostatic Gauze consists of zeolite and gauze.Zeolite Hemostatic Gauze is provided
• 06972060310532: The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressi