Catalog Number

1503832

Brand Name

Ostene

Version/Model Number

1503832

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

MTJ

Product Code Name

WAX,BONE

Public Device Record Key

48f6ab30-97f8-4eed-9365-cc8e6d9c536f

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

55413760467462

Quantity per Package

12

Contains DI Package

05413760467467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE