Catalog Number

66800418

Brand Name

ACTICOAT FLEX3 8" X 16"

Version/Model Number

66800418

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

K083113,K083113,K083113

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

080aef10-23d9-42c5-bbb4-177c96b865ef

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2020

Package DI Number

00040565125022

Quantity per Package

6

Contains DI Package

00040565124872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton