Catalog Number

-

Brand Name

ECG Snap Electrodes

Version/Model Number

7102

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093327,K093327,K093327

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

8a1717ab-49f1-4d9a-9280-47ddb2b09306

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00616784710235

Quantity per Package

150

Contains DI Package

00616784710228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-