Catalog Number

-

Brand Name

Rhythmlink®

Version/Model Number

TCN5125

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

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

e0b3b1e3-d2e0-4d20-8bac-d5f234026499

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

10816312026402

Quantity per Package

3

Contains DI Package

00816312026405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Product Box