Catalog Number

-

Brand Name

JointVue 3D Echo

Version/Model Number

1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 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

-

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

K172513

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

ae11222c-fe88-4e8c-8625-a85aac9ca7b5

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

January 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-