Catalog Number

6602133005

Brand Name

Iodoflex Dressing 5x5g USA

Version/Model Number

6602133005

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)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190756,K190756,K190756

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

5922bb91-a49d-42e0-86f3-fdd0758dfb93

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

00040565122519

Quantity per Package

5

Contains DI Package

00040565122502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton