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 sterile and self-adhesive dressing. The central pad (6"x4") is made of non-woven viscose fibers with a non-adherent fenestrated layer for wound contact. The backing (8"x6") is composed of polyurethane and Spunlace fabric with adhesive. This dressing is ideal for minimally exuding wounds, reducing the risk of damage and other contaminations. Individually packed and sterile for convenience. FDA UDI
- Model / Reference
- BG8630 FDA UDI
- Description
- Areza Island Wound Dressing (Bordered Gauze) is a sterile and self-adhesive dressing. The central pad (6"x4") is made of non-woven viscose fibers with a non-adherent fenestrated layer for wound contact. The backing (8"x6") is composed of polyurethane and Spunlace fabric with adhesive. This dressing is ideal for minimally exuding wounds, reducing the risk of damage and other contaminations. Individually packed and sterile for convenience. FDA UDI
Identifiers
- Catalog Number
- BG8630 FDA UDI
- Primary DI / UDI-DI
- 00850021481728 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 — 8 Inch FDA UDIWidth — 6 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 6b49dd86-042c-4100-a8e1-496aeca93673 36 fields · synced Jun 1, 2026