Catalog Number

639-055

Brand Name

Classic Stepper

Version/Model Number

639-055

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

bfcb074d-d359-49bf-b3f7-2c0147cdf471

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

August 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-