Catalog Number

51414

Brand Name

UHF22 Transducer

Version/Model Number

51414-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2024

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

K160674

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

c97475f5-4afd-491a-bf0c-85821af25788

Public Version Date

March 02, 2020

Public Version Number

2

DI Record Publish Date

January 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-