Catalog Number

FPRD-004

Brand Name

DERMADRY

Version/Model Number

TOTAL

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"

-

For Single-Use

-

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

K192749

Product Code

EGJ

Product Code Name

Device, Iontophoresis, Other Uses

Public Device Record Key

5b62255b-41c2-43d6-89cc-05d15ed80ab9

Public Version Date

March 25, 2020

Public Version Number

1

DI Record Publish Date

March 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-