Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Transparent Adhesive Film Dressing - 12" x 8" (5) consists of a thin polyurethane (PU) film, with a hypoallergenic, latex-free,adhesive that gently, yet securely, adheres to the skin. They are breathable, sterile, transparent, and water-resistant. It may beused as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to externalcontaminants. FDA UDI
- Model / Reference
- TF1285 FDA UDI
- Description
- Transparent Adhesive Film Dressing - 12" x 8" (5) consists of a thin polyurethane (PU) film, with a hypoallergenic, latex-free,adhesive that gently, yet securely, adheres to the skin. They are breathable, sterile, transparent, and water-resistant. It may beused as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to externalcontaminants. FDA UDI
Identifiers
- Catalog Number
- TF1285 FDA UDI
- Primary DI / UDI-DI
- 00810147401277 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
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 — 12 Inch FDA UDIWidth — 8 Inch FDA UDI
Category: Synthetic polymer semi-permeable film dressing, adhesive
Areza Medical by Advanced Medical Associates, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Synthetic polymer semi-permeable film dressing, adhesive.
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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
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI 1e2b7548-e6c9-40d4-b807-d4c43a61f66d 37 fields · synced May 30, 2026