Identity
- Trade Name
- Omni-stat Hemostatic Gauze FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only FDA UDI
- Model / Reference
- FG07734331 FDA UDI
- Description
- Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only FDA UDI
Identifiers
- Catalog Number
- FG07734331 FDA UDI
- Primary DI / UDI-DI
- 15060206630595 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Chitosan haemostatic agent, professional, non-bioabsorbable 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
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
- Width — 17 Millimeter FDA UDILength — 120 Millimeter FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
Omni-stat Hemostatic Gauze by Medtrade Products , Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.
- HemCon ChitoGauze XR2 Pro, 3in x 4yd — Tricol Biomedical, INC. · U
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- HemCon® OneStop™ Bandage, 2in x 2in — Tricol Biomedical, INC. · U
- PosiSep X2 0.8" x 2.3" — Hemostasis, LLC · Class I
- Axiostat Patch — Advamedica, Inc. · U
- GuardaCare® PRO, 4in x 4in, 8ply — Tricol Biomedical, INC. · U
- MaxioCel Chitosan Wound Dressing — Advamedica, Inc. · U
- HemCon® Patch PRO, 2in x 2in — Tricol Biomedical, INC. · U
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
- Medtrade Products , Ltd.
Sources (1)
- FDA UDI 802d279c-0ea5-44b8-81ae-04de5d2040e2 36 fields · synced Jun 8, 2026