Catalog Number

-

Brand Name

10V4 Transducer

Version/Model Number

11319697

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

K180039,K201130

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

6e7abdbe-436b-4035-a664-6d7ada962a72

Public Version Date

November 18, 2021

Public Version Number

8

DI Record Publish Date

February 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-