Identity
- Trade Name
- CELOX Gauze Z-Fold FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules. The dressing is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions. For use by trained emergency responders. FDA UDI
- Model / Reference
- FG08838181 FDA UDI
- Description
- Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules. The dressing is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions. For use by trained emergency responders. FDA UDI
Identifiers
- Catalog Number
- FG08838181 FDA UDI
- Primary DI / UDI-DI
- 15060206631394 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
No
FDA UDI
Over-the-Counter
Yes
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
- Length — 5 Feet FDA UDIWidth — 3 Inch FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
CELOX Gauze Z-Fold by Medtrade Products , Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.
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- 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 509785fb-c4ab-4a44-a633-0a3db40d8b96 36 fields · synced May 30, 2026