Catalog Number

-

Brand Name

DermaGinate/Ag

Version/Model Number

00535E

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,K143335

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

e55c9ffc-b91c-4921-848d-1d05642e206d

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-