QuikClot

FDA UDI

Class U (US FDA UDI)

by Z-Medica, LLC

Identity

Trade Name: QuikClot FDA UDI
Generic Name: Non-organic haemostatic agent FDA UDI
Device Name: BTK+, CG LE, H&H, Orange SOFTT-W,Large FDA UDI
Model / Reference: 0534 FDA UDI
Description: BTK+, CG LE, H&H, Orange SOFTT-W,Large FDA UDI

Identifiers

Catalog Number: 0534 FDA UDI
Primary DI / UDI-DI: 00841495105340 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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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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 9be0c526-f699-453e-a6c4-42f5bdc41161 35 fields · synced May 30, 2026