Catalog Number

ST148

Brand Name

Pretika

Version/Model Number

ST148

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

2bc57779-f01f-4cf1-9a1d-87faa473384e

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 19, 2021

Package DI Number

10813859001480

Quantity per Package

6

Contains DI Package

00813859001483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box