Xstat

FDA UDI

Class II (US FDA UDI)

by Revmedx, Inc.

Identity

Trade Name: XSTAT FDA UDI
Generic Name: Radiopaque woven surgical sponge FDA UDI
Device Name: A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked with an X-shaped radiopaque marker. FDA UDI
Model / Reference: XSTAT 12 FDA UDI
Description: A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked with an X-shaped radiopaque marker. FDA UDI

Identifiers

Catalog Number: FIN-0001-04 FDA UDI
Primary DI / UDI-DI: 00851587006042 FDA UDI
FDA Product Code: PGZ FDA UDI
NAB FDA UDI
GMDN Term: Radiopaque woven surgical sponge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4452 FDA UDI
878.4014 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 12 Millimeter FDA UDI

Category: Radiopaque woven surgical sponge

Xstat by Revmedx, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Revmedx, Inc.

Sources (1)

FDA UDI 64666c0f-ab1c-4ccd-b2e9-180b4043f734 37 fields · synced Jun 8, 2026