Catalog Number

-

Brand Name

DeScribe Transparent PFD Patch

Version/Model Number

PFD-462

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

PKO

Product Code Name

Transparent Patch For Use In Treatment Of Tattoos

Public Device Record Key

48138b39-43cd-4c44-b44c-75bb61841a4f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10864525000207

Quantity per Package

15

Contains DI Package

00864525000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box