Catalog Number

-

Brand Name

FINELINE® II Sterox

Version/Model Number

4456

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P960004,P960004,P960004,P960004,P960004,P960004,P960004

Product Code

DTB

Product Code Name

permanent pacemaker Electrode

Public Device Record Key

3771f8cf-46fe-4c52-9c09-410e55d4c8f0

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-