Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing. FDA UDI
- Model / Reference
- 45334 FDA UDI
- Description
- Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing. FDA UDI
Identifiers
- Catalog Number
- 45334 FDA UDI
- Primary DI / UDI-DI
- 00850021481032 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial 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 — 2.5 Inch FDA UDIArea/Surface Area — 6.25 Square inch FDA UDIWidth — 2.5 Inch FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Areza Medical by Advanced Medical Associates, 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
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI bff40e0f-5f9e-46e2-832c-bf88ce349af0 37 fields · synced Jun 7, 2026