Catalog Number

-

Brand Name

Convex probe

Version/Model Number

MC3-A

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

K131305,K131305,K131305

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

9ea7e3ce-fffe-450e-aa32-5089da049d53

Public Version Date

September 05, 2022

Public Version Number

6

DI Record Publish Date

December 30, 2016

Package DI Number

06945121407458

Quantity per Package

1

Contains DI Package

06945121407373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-