Catalog Number

-

Brand Name

Connection Cable Remote Control / RF-Generator

Version/Model Number

S7040

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

-

Product Code

DRF

Product Code Name

Catheter, Electrode Recording, Or Probe, Electrode Recording

Public Device Record Key

4c49f8d5-6f5f-4611-ab4c-5f90fe64d14c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-