Catalog Number

124697

Brand Name

S 60-F

Version/Model Number

124697

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

DTB

Product Code Name

permanent pacemaker Electrode

Public Device Record Key

75e065c2-da88-40ef-b70e-005d7b53f7dd

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

August 19, 2014

Package DI Number

04035479012366

Quantity per Package

10

Contains DI Package

04035479145057

Package Discontinue Date

October 05, 2022

Package Status

Not in Commercial Distribution

Package Type

case