Catalog Number

-

Brand Name

TattooStar

Version/Model Number

1641

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2018

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

K060787

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

d0b71750-92fd-4c9c-8439-3ac0fb7e60ff

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

June 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-