Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Areza Sacral Ultra-Absorbent Foam with Adhesive Border and Flaps consists of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing. The multi-layer construction facilitates dynamic fluid management to provide an optimal moist wound environment known to promote faster wound healing. Dynamic fluid management may help reduce the risk of maceration. The gentle silicone layer can significantly minimize pain and trauma to the wound and its surrounding skin during dressing change. The two main absorbent layers- PU foam and ultra-absorbent polyacrylate, provide superior absorption and lock exudates away. The PU backing is waterproof and vapor permeable and may protect against contaminations by external fluids and organisms. FDA UDI
- Model / Reference
- SSF91010 FDA UDI
- Description
- Areza Sacral Ultra-Absorbent Foam with Adhesive Border and Flaps consists of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing. The multi-layer construction facilitates dynamic fluid management to provide an optimal moist wound environment known to promote faster wound healing. Dynamic fluid management may help reduce the risk of maceration. The gentle silicone layer can significantly minimize pain and trauma to the wound and its surrounding skin during dressing change. The two main absorbent layers- PU foam and ultra-absorbent polyacrylate, provide superior absorption and lock exudates away. The PU backing is waterproof and vapor permeable and may protect against contaminations by external fluids and organisms. FDA UDI
Identifiers
- Catalog Number
- SSF91010 FDA UDI
- Primary DI / UDI-DI
- 00850021481001 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 — 9.1 Inch FDA UDIWidth — 10.2 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
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.
- Suprasorb — Huizhou Foryou Medical Devices Co., Ltd. · Class I
- Proximel Silicone Dressing 5x5 — HARTMANN USA INC. · Class I
- Healqu — HEALQU LLC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Curity — Cardinalhealth · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI 85b8c2f1-fc8a-49d4-a042-512dc18f537c 37 fields · synced May 31, 2026