Catalog Number

0607-687-000

Brand Name

AutoPlex, VertaPlex

Version/Model Number

0607687000

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

a50504d6-7fe8-4f8a-87bd-23cb3f042151

Public Version Date

March 03, 2021

Public Version Number

6

DI Record Publish Date

January 03, 2017

Package DI Number

37613252039250

Quantity per Package

2

Contains DI Package

07613252039259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack