Catalog Number

-

Brand Name

AtriAmp - Pacing Cable

Version/Model Number

10039

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

K200674,K200674,K200674

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

60a8945e-4d80-4153-aecb-2d07af24b219

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Package DI Number

10860004773716

Quantity per Package

5

Contains DI Package

00860004773719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton