Catalog Number

0406-402-015

Brand Name

VertaPlex

Version/Model Number

0406402015

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

NDN

Product Code Name

CEMENT, BONE, VERTEBROPLASTY

Public Device Record Key

8ff4a4c0-268c-43aa-9e1e-5425d1b0e8d6

Public Version Date

October 20, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

57613327170561

Quantity per Package

22

Contains DI Package

07613327170566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case