Catalog Number

20141

Brand Name

ACTICOAT 7 4" X 5"

Version/Model Number

20141

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K001519,K001519,K001519

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

5dd2dd03-7ddb-4d66-80e4-a00e3252e54b

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2020

Package DI Number

00040565121376

Quantity per Package

5

Contains DI Package

05000223449919

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton