Identity
- Trade Name
- QuiCover FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- P0910122 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972060310174 FDA UDI
- 510(k) Number
- K211570 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Non-organic haemostatic agent FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-organic haemostatic agent
QuiCover by Hangzhou Zeo-Innov Life Technology Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211570 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Zeo-Innov Life Technology Co., Ltd.
Sources (1)
- FDA UDI 0d6b7e68-be45-43dc-8e9b-ce0bfc6f3caf 35 fields · synced May 31, 2026