Catalog Number

0916

Brand Name

TRACE 1

Version/Model Number

0916

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

-

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

5ef770f6-6cd1-4643-ae00-88ed5d1e9f61

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

Package DI Number

20853512006657

Quantity per Package

10

Contains DI Package

10853512006650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bx