Catalog Number

-

Brand Name

Silverlon Antimicrobial Wound Dressing

Version/Model Number

WCD1212-NPS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

b3e21954-c1fd-4af5-934c-83b92342fdc0

Public Version Date

September 16, 2021

Public Version Number

3

DI Record Publish Date

November 30, 2018

Package DI Number

00840247300033

Quantity per Package

5

Contains DI Package

00857278000849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-