Catalog Number

VV-PLUG

Brand Name

VV-PLUG

Version/Model Number

VV-PLUG

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K862966

Product Code

DTB

Product Code Name

Permanent Pacemaker Electrode

Public Device Record Key

f9ca5a7a-89a3-4cf3-9501-fe037bb3ad56

Public Version Date

March 19, 2021

Public Version Number

6

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-