QuiCover

GUDID 06972060310532

The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.

Hangzhou Zeo-Innov Life Technology Co., Ltd.

Non-organic haemostatic agent

• Primary Device ID: 06972060310532
• NIH Device Record Key: eda44c6d-71bc-4c62-be7f-a7038e6bf8e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuiCover
• Version Model Number: 0.3g
• Company DUNS: 541290694
• Company Name: Hangzhou Zeo-Innov Life Technology Co., Ltd.
• Device Count: 8
• 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 Dimensions

• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram
• Weight: 10 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972060310532 [Primary]
GS1	06972060310563 [Package]; Package: carton [60 Units]; In Commercial Distribution
GS1	06972060310570 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223495

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: 2024-04-30
• Device Publish Date: 2024-04-22

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