Identity
- Trade Name
- UBZ FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. CoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. STD W/IN TN/WH 4" FDA UDI
- Model / Reference
- STD W/IN TN/WH 4" FDA UDI
- Description
- Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. CoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. STD W/IN TN/WH 4" FDA UDI
Identifiers
- Catalog Number
- 8840UBZ-SC FDA UDI
- Primary DI / UDI-DI
- 10724004619897 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
Yes
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
Ubz by Andover Healthcare Inc. — 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
- Andover Healthcare Inc.
Sources (1)
- FDA UDI 88fbdbc2-e88a-46e6-8bb4-a3c914e7b4fc 35 fields · synced Jun 6, 2026