Catalog Number

-

Brand Name

HiVac™ Bowl Bone Cement Mixing System

Version/Model Number

B713

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

ff6854fb-f264-46b0-86ae-a2aa12162ce4

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

Package DI Number

25060238200282

Quantity per Package

15

Contains DI Package

15060238200285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton