Catalog Number

400440

Brand Name

Prontosan®

Version/Model Number

400440

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"

Yes

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

-

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

0e8dec05-3f1d-4893-a6fa-9cc973e83320

Public Version Date

March 18, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

04046964295744

Quantity per Package

5

Contains DI Package

04046964295751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack