Catalog Number

66021771

Brand Name

ACTICOAT SURGIC 10X20CM 5PK US

Version/Model Number

66021771

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

K153723,K153723,K153723

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

2cfee24c-0668-4902-b001-38e549922e8b

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

August 06, 2020

Package DI Number

05000223459345

Quantity per Package

5

Contains DI Package

05000223477394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton