Catalog Number

-

Brand Name

Silverlon Antimicrobial Wound Dressing

Version/Model Number

CA-475

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

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

49503fcc-a75b-4f34-8638-4811d5be93e5

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

September 30, 2020

Package DI Number

10857278000419

Quantity per Package

10

Contains DI Package

00857278000412

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-