Catalog Number

-

Brand Name

7L4A Ultrasonic Transducer(FDA)

Version/Model Number

PL1J-30-90759

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K140030

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

fc7b97fc-4054-4a1c-991c-89ec25a87c10

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-