Catalog Number

VCF-1051

Brand Name

ZAVATION

Version/Model Number

CEMENT MIXING SYSTEM

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"

Yes

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

54538d29-d9da-4fca-a470-50a95efab867

Public Version Date

June 13, 2018

Public Version Number

3

DI Record Publish Date

February 26, 2018

Package DI Number

08033860028039

Quantity per Package

10

Contains DI Package

08033860028022

Package Discontinue Date

February 26, 2018

Package Status

Not in Commercial Distribution

Package Type

POUCH