Catalog Number

-

Brand Name

EC9-4 Transducer

Version/Model Number

11286590

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

K121646,K121699,K141846,K173957,K173981

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

78cb60fc-ac43-4251-a6b7-9530f460703f

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

March 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-