Identity
- Trade Name
- CELOX Vascular FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- Hemostatic Pad: The device is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16 French. The hemostatic pad is for temporary external use only. FDA UDI
- Model / Reference
- FG08834081 FDA UDI
- Description
- Hemostatic Pad: The device is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16 French. The hemostatic pad is for temporary external use only. FDA UDI
Identifiers
- Catalog Number
- FG08834081 FDA UDI
- Primary DI / UDI-DI
- 15060206630649 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
- Length — 2 Inch FDA UDIWidth — 2 Inch FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
CELOX Vascular by Medtrade Products , Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 99d9ece5-2afb-4565-9d1c-6ee3e81b3592 36 fields · synced May 30, 2026