Catalog Number

ST102

Brand Name

Pretika

Version/Model Number

ST102

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GFE

Product Code Name

Brush, dermabrasion, powered

Public Device Record Key

50ffe01b-00a4-4489-b273-e6b29e060c29

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Package DI Number

10813859001022

Quantity per Package

4

Contains DI Package

00813859001025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box