Catalog Number

V0500002

Brand Name

VISIONAIRE UNI

Version/Model Number

V0500002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 06, 2022

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

K172650,K173970,K202207

Product Code

HSX

Product Code Name

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Public Device Record Key

5d84c56a-ebfb-4215-97ab-e4ade3637284

Public Version Date

October 07, 2022

Public Version Number

5

DI Record Publish Date

April 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-