Silverlon Antimicrobial Wound Dressing - Hydrocolloid Island Dressing 4" x 12" - ARGENTUM MEDICAL, LLC

Duns Number:091449079

Device Description: Hydrocolloid Island Dressing 4" x 12"

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More Product Details

Catalog Number

-

Brand Name

Silverlon Antimicrobial Wound Dressing

Version/Model Number

IDHC-412

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

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

ae8511dd-3631-43fa-8955-2ae739320a38

Public Version Date

July 28, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2021

Additional Identifiers

Package DI Number

00840247300026

Quantity per Package

5

Contains DI Package

00857278000894

Package Discontinue Date

-

Package Status

In Commercial Distribution

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