Xstat P30

FDA UDI

Class II (US FDA UDI)

by Revmedx, Inc.

Identity

Trade Name: XSTAT P30 FDA UDI
Generic Name: Radiopaque woven surgical sponge FDA UDI
Device Name: Hemostatic device for severe bleeding. Each device comprises 3 pouches containing minisponges. Each pouch contains a radiopaque marker. FDA UDI
Model / Reference: FIN-0017-21 FDA UDI
Description: Hemostatic device for severe bleeding. Each device comprises 3 pouches containing minisponges. Each pouch contains a radiopaque marker. FDA UDI

Identifiers

Catalog Number: FIN-0017-21 FDA UDI
Primary DI / UDI-DI: 00851587006226 FDA UDI
510(k) Number: K210676 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 — 28.5 Millimeter FDA UDI

Category: Radiopaque woven surgical sponge

Xstat P30 by Revmedx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque woven surgical sponge.

SurgiCount Safety-Sponge — Stryker Corp. · Class I
DuLap® — Derma Sciences Canada, Inc · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
ORLocate — STERIS CORPORATION · Class I
Kerlix — Cardinalhealth · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
AMD-RITMED — AMD Medicom Inc · Class I
Dukal — Dukal LLC · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Revmedx, Inc.

Sources (1)

FDA UDI 7f9d43a2-36b6-4352-965c-6ae84e695a29 38 fields · synced May 30, 2026