Catalog Number

3908438

Brand Name

Prontosan®

Version/Model Number

3908438

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

7fbd6ead-3dd1-4466-ba13-088fdcaa1f78

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

07612449140426

Quantity per Package

16

Contains DI Package

07612449140419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton