Identity
- Trade Name
- UNNA-FLEX FDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- UNNA-FLEX QUALINEX BNDG KIT (1X12PK) US FDA UDI
- Model / Reference
- 650944 FDA UDI
- Description
- UNNA-FLEX QUALINEX BNDG KIT (1X12PK) US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455201020 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
No
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Length — 9.14000 Meter FDA UDIWidth — 10.00000 Centimeter FDA UDI
Category: Pressure bandage, non-latex, single-use
Unna-Flex by Convatec, Purchasing Department — 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
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 9c243480-6b66-4f50-be97-66d3a834c275 35 fields · synced Jun 8, 2026