Catalog Number

SMLV

Brand Name

MiniMix LV

Version/Model Number

SMLV

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

88be0d29-21c0-417d-bf07-ad7cff75c07f

Public Version Date

November 07, 2019

Public Version Number

1

DI Record Publish Date

October 30, 2019

Package DI Number

25060238200749

Quantity per Package

10

Contains DI Package

15060238200742

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton