Catalog Number

-

Brand Name

Electrophysiology Cable

Version/Model Number

M004603S0

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

-

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

P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P980003

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

87e9dfa1-8423-4f69-9265-da2b1ad6ef10

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-