Catalog Number

-

Brand Name

Medvat

Version/Model Number

5L4C

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

K955246,K955246

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

f5e4f1e3-ca34-493d-a36c-a2acf027b359

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 21, 2021

Package DI Number

00850024089549

Quantity per Package

4

Contains DI Package

00850024089518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box