Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- The dressing is made from natural alginate fibers and silver. Silver particle in the dressing can restrain growth of biologic pathogens in the wound and help reduce further wound infection. The dressing has been tested in vitro and found to be effective against several important biologic pathogens affecting wounds. It is designed to be highly absorbent. The dressing, while absorbing wound drainage (exudates), forms a gel-like covering over the wound, which provides an ideal moist environment. Moist wound healing is known to expedite wound healing. The gel-like surface also prevents the dressing from adhering to the wound, making removal painless. FDA UDI
- Model / Reference
- SA425100 FDA UDI
- Description
- The dressing is made from natural alginate fibers and silver. Silver particle in the dressing can restrain growth of biologic pathogens in the wound and help reduce further wound infection. The dressing has been tested in vitro and found to be effective against several important biologic pathogens affecting wounds. It is designed to be highly absorbent. The dressing, while absorbing wound drainage (exudates), forms a gel-like covering over the wound, which provides an ideal moist environment. Moist wound healing is known to expedite wound healing. The gel-like surface also prevents the dressing from adhering to the wound, making removal painless. FDA UDI
Identifiers
- Catalog Number
- SA425100 FDA UDI
- Primary DI / UDI-DI
- 00850021481810 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Classification
- Device Class
- U 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
No
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 — 4.25 Inch FDA UDIWidth — 4.25 Inch FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Areza Medical by Advanced Medical Associates, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
- DermaGinate/Ag — DERMARITE INDUSTRIES LLC · U
- AQUACEL AG+ — CONVATEC, PURCHASING DEPARTMENT · U
- 3M™ Silvercel™ — 3M Deutschland GmbH · U
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED · U
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD. · U
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc · U
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI 11f70718-533e-43b7-8041-e6086c8c3881 36 fields · synced May 30, 2026