Catalog Number

-

Brand Name

Transducer

Version/Model Number

10C-D

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

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

b355f748-c69e-4b62-81f0-ca593a25ed26

Public Version Date

October 22, 2018

Public Version Number

2

DI Record Publish Date

September 18, 2018

Package DI Number

24589509510017

Quantity per Package

1

Contains DI Package

14589509510010

Package Discontinue Date

September 07, 2048

Package Status

In Commercial Distribution

Package Type

Case