Identity
- Trade Name
- HemCon® OneStop™ Bandage, 2in x 2in, OTC FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms. FDA UDI
Identifiers
- Catalog Number
- 1112 FDA UDI
- Primary DI / UDI-DI
- 00870053000360 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
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon® OneStop™ Bandage, 2in x 2in, OTC by Tricol Biomedical, INC. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.
- Celox Rapid Z-Fold Gauze — Medtrade Products , Ltd. · U
- QUIKCLOT — TELEFLEX INCORPORATED · U
- CELOX Gauze — Medtrade Products , Ltd. · U
- PosiSep X2 0.8" x 2.3" — Hemostasis, LLC · Class I
- CELOX Vascular — Medtrade Products , Ltd. · U
- Axiostat Patch — Advamedica, Inc. · U
- MaxioCel Chitosan Wound Dressing — Advamedica, Inc. · U
- Axiostat Gauze — Advamedica, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tricol Biomedical, INC.
Sources (1)
- FDA UDI fb19ad8e-c9fd-49f4-b920-8cce715208c0 35 fields · synced Jun 8, 2026