Identity
- Trade Name
- QuikClot FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- QuikClot Bleeding Control Dressing 3"x4yd,1x FDA UDI
- Model / Reference
- 0538 FDA UDI
- Description
- QuikClot Bleeding Control Dressing 3"x4yd,1x FDA UDI
Identifiers
- Catalog Number
- 0538 FDA UDI
- Primary DI / UDI-DI
- 00841495105388 FDA UDI
- 510(k) Number
- K072474 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Non-organic haemostatic agent
QuikClot by Z-Medica, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K072474 also covers:
- QUIKCLOT — TELEFLEX INCORPORATED
- QUIKCLOT — TELEFLEX INCORPORATED
- QUIKCLOT — TELEFLEX INCORPORATED
- QUIKCLOT — TELEFLEX INCORPORATED
- QUIKCLOT — TELEFLEX INCORPORATED
- QuikClot — Z-Medica, LLC
- QuikClot — Z-Medica, LLC
- QuikClot — Z-Medica, LLC
- QuikClot — Z-Medica, LLC
- QuikClot — Z-Medica, LLC
- QuikClot — Z-Medica, LLC
- QuikClot — Z-Medica, LLC
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
- Z-Medica, LLC
Sources (1)
- FDA UDI 48206269-de5c-4ebc-9ca6-8df0d76664d5 36 fields · synced May 30, 2026