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 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker. FDA UDI
- Model / Reference
- XSTAT 30 FDA UDI
- Description
- A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker. FDA UDI
Identifiers
- Catalog Number
- FIN-0001-03 FDA UDI
- Primary DI / UDI-DI
- 00851587006059 FDA UDI
- 510(k) Number
- K152624 FDA UDI
- FDA Product Code
- PGZ FDA UDI
- GMDN Term
- Radiopaque woven surgical sponge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4452 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Outer Diameter — 30 Millimeter FDA UDI
Xstat by Revmedx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 b3ad1c65-4320-4ef6-9b09-bff965961e58 39 fields · synced Jun 8, 2026