Catalog Number

-

Brand Name

PROXIMEL AG SILICONE DRESSING 6x6 5/BX

Version/Model Number

15300000

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

ab34dbfb-1220-49c7-81d5-f701162405cb

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

20612553023500

Quantity per Package

5

Contains DI Package

10612553023503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-