NuMed Industries LLC. - NuMed Silver Alginate Rope Dressing, conformable - Numed Industries, LLC

Duns Number:964438910

Device Description: NuMed Silver Alginate Rope Dressing, conformable wound dressings with a high mannuronic ac NuMed Silver Alginate Rope Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days.

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More Product Details

Catalog Number

-

Brand Name

NuMed Industries LLC.

Version/Model Number

B-NM3530SAD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120181,K120181

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

55dadb3b-b5be-4690-9c02-39f0f29c651c

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUMED INDUSTRIES, LLC" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 10