Catalog Number

1750504

Brand Name

14L3e Linear Array Transducer

Version/Model Number

14L3e Linear Array Transducer

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 2020

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

K150342

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

ccf7de8e-40e5-4a14-b25f-8be7dc0a850b

Public Version Date

May 20, 2020

Public Version Number

5

DI Record Publish Date

January 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-