Catalog Number

-

Brand Name

DermaGinate/Ag

Version/Model Number

00530E

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143335

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

5f89a0d1-cbfa-48a4-9a13-a44a8b729846

Public Version Date

September 17, 2021

Public Version Number

1

DI Record Publish Date

September 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-