Silverlon Antimicrobial Wound Dressing - Burn Wrap Dressing 4in x 66in - ARGENTUM MEDICAL, LLC

Duns Number:091449079

Device Description: Burn Wrap Dressing 4in x 66in

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More Product Details

Catalog Number

-

Brand Name

Silverlon Antimicrobial Wound Dressing

Version/Model Number

BWD-466

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"

-

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

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

a9c3e066-3dbf-4c17-b727-5480c9131404

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARGENTUM MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13
U Unclassified 100