Catalog Number

-

Brand Name

Advantage Medical Cable ECG Leads

Version/Model Number

RM-LW-209DS50/3A

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

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

e0afa280-8f61-4e0b-91fa-e06c89141464

Public Version Date

August 02, 2019

Public Version Number

3

DI Record Publish Date

June 16, 2017

Package DI Number

10816317023222

Quantity per Package

25

Contains DI Package

00816317023225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-