Catalog Number

-

Brand Name

Vivid

Version/Model Number

E95 R4 LCD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200743

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

176e67c8-2507-4af5-99eb-14924aa43cb4

Public Version Date

October 25, 2022

Public Version Number

2

DI Record Publish Date

March 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-