Catalog Number

390-2105

Brand Name

OsteoVation

Version/Model Number

390-2105

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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

FWP

Product Code Name

PROSTHESIS, CHIN, INTERNAL

Public Device Record Key

6964368c-ce0f-4c90-9b1b-23ed7ea73d46

Public Version Date

March 22, 2021

Public Version Number

6

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-