Catalog Number

0406-202-000

Brand Name

SpinePlex

Version/Model Number

0406202000

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

9151b2c5-cfa4-4696-a497-a833f2fd7f22

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 30, 2016

Package DI Number

34546540434365

Quantity per Package

2

Contains DI Package

04546540434364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack