Catalog Number

-

Brand Name

Osteoflex

Version/Model Number

INTV-CEM

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

e3feffd7-6985-4823-8d48-6d6d6ab7ad6a

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

November 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-