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Areza Medical

FDA UDI

Class I (US FDA UDI)

by Advanced Medical Associates, Llc

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 (6"x4") is composed of non-woven viscose fibers which on the facing surface are covered with a fenestrated non-adherent layer. The backing of the dressing (8"x6") is made of polyurethane and Spunlace fabric and is covered with 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 the risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile. FDA UDI
Model / Reference
BG8430 FDA UDI
Description
Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self-adhesive dressing. The central pad (6"x4") is composed of non-woven viscose fibers which on the facing surface are covered with a fenestrated non-adherent layer. The backing of the dressing (8"x6") is made of polyurethane and Spunlace fabric and is covered with 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 the risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile. FDA UDI

Identifiers

Catalog Number
BG8430 FDA UDI
Primary DI / UDI-DI
00850021481674 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 UDI
Width — 4 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Medical Associates, Llc

Sources (1)

  • FDA UDI c40133c8-b428-4995-982f-b60867295101 37 fields · synced May 30, 2026