Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

460

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

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

1a15916b-3d49-4351-82c8-53da0a9b4b35

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

Package DI Number

D8384608

Quantity per Package

4

Contains DI Package

D8384606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE