Catalog Number

642-443

Brand Name

EX3 Stepper

Version/Model Number

642-443

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

K131161,K131161

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

7ebbe540-bb2c-4076-a24e-de1d2a369ebd

Public Version Date

September 06, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-