Catalog Number

-

Brand Name

ONE Tattoo Touch

Version/Model Number

112002

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

bd415423-a871-4b24-a584-ea4aa52fce41

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

10726893111988

Quantity per Package

3

Contains DI Package

00726893111981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bundle of 3, 12 pack