Catalog Number

-

Brand Name

Rhythmlink®

Version/Model Number

242-550-24TP-25

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

IKT

Product Code Name

Electrode, Needle, Diagnostic Electromyograph

Public Device Record Key

3ddfefa3-3e10-4f81-b1fd-5e87996ed650

Public Version Date

August 12, 2021

Public Version Number

1

DI Record Publish Date

August 04, 2021

Package DI Number

10816312025009

Quantity per Package

25

Contains DI Package

00816312025002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Product Box