Catalog Number

H48062AJ

Brand Name

NA

Version/Model Number

L4-20t-RS

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

K202233

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

7b42832a-4e4b-4ab6-a7df-2eb9ed30b274

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-