Catalog Number

346367

Brand Name

Selox

Version/Model Number

ST 60

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 18, 2021

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

Yes

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

-

FDA Premarket Submission

-

Product Code

NVN

Product Code Name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Public Device Record Key

3beeb43b-5264-40f3-b433-a34eb6ce95e3

Public Version Date

August 19, 2021

Public Version Number

4

DI Record Publish Date

August 06, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-