Catalog Number

362703

Brand Name

Siello

Version/Model Number

JT 45

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

P950037

Product Code

NVN

Product Code Name

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

Public Device Record Key

56bd591f-e8ae-4e78-8b59-8dd9895443d5

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-