Catalog Number

ST289

Brand Name

Pretika

Version/Model Number

ST289

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

GET

Product Code Name

MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Public Device Record Key

25c4a077-af82-4bf0-ad6e-dd4d0035b07a

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Package DI Number

20813859002897

Quantity per Package

3

Contains DI Package

10813859002890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton