Identity
- Trade Name
- URGOK2 FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- UrgoK2 is a two Layer Compression System -KTECH; a short - stretch bandage, providing compression, protection and absorbency and KPRESS; a cohesive long-stretch bandage providing the compression necessary to achieve therapeutic pressure and secures the bandages in place. UrgoK2 is for the treatment of venous leg ulcers, venous edema and lymphedema requiring full compression. Not made with natural rubber latex. FDA UDI
- Model / Reference
- 553243 FDA UDI
- Description
- UrgoK2 is a two Layer Compression System -KTECH; a short - stretch bandage, providing compression, protection and absorbency and KPRESS; a cohesive long-stretch bandage providing the compression necessary to achieve therapeutic pressure and secures the bandages in place. UrgoK2 is for the treatment of venous leg ulcers, venous edema and lymphedema requiring full compression. Not made with natural rubber latex. FDA UDI
Identifiers
- Catalog Number
- 553243 FDA UDI
- Primary DI / UDI-DI
- 00190769532437 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Compression bandaging kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compression bandaging kit
Urgok2 by Urgo Medical North America, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI f626ef75-8624-47a4-ad6d-74a2a873c36b 37 fields · synced Jun 9, 2026