Catalog Number

-

Brand Name

Volume probe

Version/Model Number

VE6-T

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200780,K200780

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

aa64bb24-322d-4028-bcc2-cc7e31e12d84

Public Version Date

September 05, 2022

Public Version Number

2

DI Record Publish Date

February 10, 2022

Package DI Number

06945121413558

Quantity per Package

2

Contains DI Package

06945121413534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-