Catalog Number

66021772

Brand Name

ACTICOAT SURGIC 10X25CM 5PK US

Version/Model Number

66021772

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

cdd04321-7f95-4532-aa1c-e8800283f007

Public Version Date

June 21, 2021

Public Version Number

2

DI Record Publish Date

August 06, 2020

Package DI Number

05000223459369

Quantity per Package

5

Contains DI Package

05000223477400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton