Areza Medical - Areza Island Wound Dressing (Bordered Gauze) is a - ADVANCED MEDICAL ASSOCIATES, LLC

Duns Number:047724226

Device Description: Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and 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.

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More Product Details

Catalog Number

57255

Brand Name

Areza Medical

Version/Model Number

57255

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

893aac10-821e-44a4-8416-0496b14eae6e

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED MEDICAL ASSOCIATES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
U Unclassified 5