Catalog Number

-

Brand Name

NA

Version/Model Number

6402

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

-

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

-

FDA Premarket Submission

P150012,P150012,P150012

Product Code

NVN

Product Code Name

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

Public Device Record Key

30a0f0a2-39d7-491a-abf3-a49b76312985

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

May 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-