Catalog Number

234-500-228

Brand Name

Biosteon

Version/Model Number

234-500-228

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

-

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

NBH

Product Code Name

ACCESSORIES,ARTHROSCOPIC

Public Device Record Key

4f1b14c2-b2f3-40d6-8ade-c9f9b03cb92a

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

September 04, 2015

Package DI Number

34546540756986

Quantity per Package

6

Contains DI Package

04546540756985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack