Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

004B-LAV

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

Yes

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

92c7b21a-202c-400c-a889-a3b4a4a6faa9

Public Version Date

January 15, 2020

Public Version Number

1

DI Record Publish Date

January 07, 2020

Package DI Number

D838004LAV8

Quantity per Package

4

Contains DI Package

D838004LAV6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE