Catalog Number

402152

Brand Name

Livewire™

Version/Model Number

402152

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

P960016

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

457b04b5-ac2f-4e0a-abd3-9e7ca4fea9ca

Public Version Date

November 16, 2020

Public Version Number

4

DI Record Publish Date

October 03, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-