Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self adhesive dressing. The central pad (4"x4") is composed of non-woven viscose fibers which on wound facing surace covered with a fenestrated non-adherent layer. The backing of the dressing (6"x6") is made of polyurethane and Spunlace fabric and is covdered wih adhesives. The non-adherent wound facing layer provides this dressing the unique ability to be used on minimally exuding wounds. This conformable dressing may reduce risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile. FDA UDI
- Model / Reference
- 57255 FDA UDI
- Description
- Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self adhesive dressing. The central pad (4"x4") is composed of non-woven viscose fibers which on wound facing surace covered with a fenestrated non-adherent layer. The backing of the dressing (6"x6") is made of polyurethane and Spunlace fabric and is covdered wih adhesives. The non-adherent wound facing layer provides this dressing the unique ability to be used on minimally exuding wounds. This conformable dressing may reduce risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile. FDA UDI
Identifiers
- Catalog Number
- 57255 FDA UDI
- Primary DI / UDI-DI
- 00850021481292 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
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 893aac10-821e-44a4-8416-0496b14eae6e 36 fields · synced May 30, 2026