Catalog Number

2010

Brand Name

TRACE 1

Version/Model Number

2010

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

Yes

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

K022909,K022909,K022909,K022909

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

e0e61742-79a6-4ce8-90ba-88c19a21535f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 17, 2017

Package DI Number

30853512006432

Quantity per Package

12

Contains DI Package

20853512006435

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cs