Catalog Number

-

Brand Name

Silverlon Antimicrobial Wound Dressing

Version/Model Number

BCD-816

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)

-

Over the Counter (OTC)

Yes

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

d7d5c11e-24d5-40a4-a47b-9207e5b89969

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

10857278000525

Quantity per Package

5

Contains DI Package

00857278000528

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-