Catalog Number

22661P

Brand Name

Medi-Trace Cadence

Version/Model Number

22661P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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

DRO

Product Code Name

PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Public Device Record Key

5a44156b-2e4f-4b3a-95e3-4ad73f7b2cb1

Public Version Date

July 30, 2021

Public Version Number

8

DI Record Publish Date

September 22, 2014

Package DI Number

10884527022359

Quantity per Package

5

Contains DI Package

20884527022356

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE