Catalog Number

BMT-VGCR 79

Brand Name

VERASENSE

Version/Model Number

VERASENSE for Biomet Vanguard CR size 79/83

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 03, 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

-

Product Code

ONN

Product Code Name

Intraoperative Orthopedic Joint Assessment Aid

Public Device Record Key

adc65ee0-7667-4359-ace1-af6265847dbb

Public Version Date

October 07, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-