Catalog Number

ST261

Brand Name

Pretika

Version/Model Number

ST261

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

cd433b11-5d9a-4fdb-90fe-e2954265ee8a

Public Version Date

May 13, 2020

Public Version Number

3

DI Record Publish Date

July 01, 2019

Package DI Number

10813859002616

Quantity per Package

2

Contains DI Package

00813859002619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit