Catalog Number

2014775-001

Brand Name

SilverTRACE

Version/Model Number

2014775-001

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

d5e68b8d-fef6-42df-817c-557a04a6f244

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Package DI Number

20885403251921

Quantity per Package

10

Contains DI Package

70885403251926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box