Catalog Number

292-STE

Brand Name

Single Tab Electrode

Version/Model Number

292-STE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

510002e3-edeb-4ec3-8506-b10593cd4afd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Package DI Number

B277292STE2

Quantity per Package

10

Contains DI Package

B277292STE1

Package Discontinue Date

-

Package Status

-

Package Type

Shipper