Catalog Number

71270070

Brand Name

VORTEX

Version/Model Number

71270070

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"

-

For Single-Use

Yes

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

-

Product Code

JDZ

Product Code Name

MIXER, CEMENT, FOR CLINICAL USE

Public Device Record Key

5b9e1cf1-55e0-4532-b87e-b076b1f7fd86

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 29, 2015

Package DI Number

23596010453215

Quantity per Package

4

Contains DI Package

03596010453211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX