Catalog Number

-

Brand Name

Phased array probe

Version/Model Number

P3-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

c267d107-dd2f-49ce-a585-2957952c80d3

Public Version Date

September 05, 2022

Public Version Number

5

DI Record Publish Date

September 28, 2016

Package DI Number

06945121407502

Quantity per Package

1

Contains DI Package

06945121407427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-