Catalog Number

6602125040

Brand Name

Iodosorb Ointment 40g USA

Version/Model Number

6602125040

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

K190730,K190730

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

7520ba27-d5ee-4ef5-9174-f15c1f214766

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

30040565122497

Quantity per Package

12

Contains DI Package

00040565122496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case