Catalog Number

-

Brand Name

Proximel NB AG Silicone Dressing 4x4

Version/Model Number

15713117

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

19186a52-877b-4d87-9b4c-d88ba4be073e

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

04052199501628

Quantity per Package

10

Contains DI Package

04052199501611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-