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 6" x 6" (pad: 4.15" x 4.15") is a superior absorbent dressing for moderate to high wound exudates management. This sterile dressing helps maintain a moist wound healing environment with no irritation upon removal, minimizes trauma to the wound, and reduces pain during dressing changes. The advanced multi-layer design helps provide high breathability to reduce the risk of maceration and protects against external bacteria. FDA UDI
- Model / Reference
- 45330 FDA UDI
- Description
- Ultra-Absorbent Silicone Foam with Adhesive Border 6" x 6" (pad: 4.15" x 4.15") is a superior absorbent dressing for moderate to high wound exudates management. This sterile dressing helps maintain a moist wound healing environment with no irritation upon removal, minimizes trauma to the wound, and reduces pain during dressing changes. The advanced multi-layer design helps provide high breathability to reduce the risk of maceration and protects against external bacteria. FDA UDI
Identifiers
- Catalog Number
- 45330 FDA UDI
- Primary DI / UDI-DI
- 00850021481049 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 — 4.15 Inch FDA UDIWidth — 4.15 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 f36547d1-222b-41f4-a56f-bbb885b1d4ee 37 fields · synced Jun 8, 2026