Identity
- Trade Name
- UnnaCare 4x6 FDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- A 4" x6"sterile or non sterile strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return).it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device. FDA UDI
- Model / Reference
- ZO1050-01 FDA UDI
- Description
- A 4" x6"sterile or non sterile strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return).it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- UC6 FDA UDI
- Primary DI / UDI-DI
- 00856525007907 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Pressure bandage, non-latex, single-use 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
Yes
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Pressure bandage, non-latex, single-use
UnnaCare 4x6 by Sun-Scientific 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
- Sun-Scientific Inc.
Sources (1)
- FDA UDI 1b9c3e1c-74bb-4e83-9ca5-cf2b872e7563 36 fields · synced May 31, 2026