Catalog Number

-

Brand Name

Silverlon Antimicrobial Wound Dressing

Version/Model Number

WCD88-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

b7fc190a-e49e-438a-a500-8d25862aea8b

Public Version Date

October 13, 2020

Public Version Number

1

DI Record Publish Date

October 05, 2020

Package DI Number

10857278000860

Quantity per Package

5

Contains DI Package

00857278000863

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-