Catalog Number

-

Brand Name

Phased array probe

Version/Model Number

P2M-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

a26a9cc7-3da9-43c8-8cb5-8aa3ec76b475

Public Version Date

October 25, 2022

Public Version Number

3

DI Record Publish Date

August 23, 2022

Package DI Number

06945121414449

Quantity per Package

2

Contains DI Package

06945121414005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-