Catalog Number

SNN-JRNYBCS12-R

Brand Name

VERASENSE

Version/Model Number

VERASENSE for Smith & Nephew Journey II BCS 1-2 Right

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 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

9b670367-95ce-4f71-b9b7-4772f3d5a0b1

Public Version Date

October 07, 2022

Public Version Number

6

DI Record Publish Date

November 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-