Areza Medical - Areza Silicone Gel Sheet for Scars is a thin, - ADVANCED MEDICAL ASSOCIATES, LLC

Duns Number:047724226

Device Description: Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone

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More Product Details

Catalog Number

SG4X43

Brand Name

Areza Medical

Version/Model Number

SG4X43

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

-

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

4ed75ddc-b30f-4696-8e2b-3f465fa32d84

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