Catalog Number

-

Brand Name

DIAGNOSTIC ULTRASOUND SYSTEM

Version/Model Number

CUS-AA550

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

K182427

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

04564f11-3d3e-4052-8203-50e98faea5e9

Public Version Date

March 07, 2019

Public Version Number

1

DI Record Publish Date

February 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-