Catalog Number

0406-202-010

Brand Name

SpinePlex

Version/Model Number

0406202010

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

49737dee-714b-4bac-8692-ad0b1121b39b

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

37613327141789

Quantity per Package

10

Contains DI Package

07613327141788

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack