Catalog Number

71270050

Brand Name

MIXOR

Version/Model Number

71270050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2018

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

-

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

24729c20-a186-4d00-8ca2-3b508929e0e8

Public Version Date

October 11, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-