Catalog Number

08257

Brand Name

Sensei®

Version/Model Number

08257

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2016

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXX

Product Code Name

System, Catheter Control, Steerable

Public Device Record Key

a670efd8-07ba-433d-b1f5-7df7c312b337

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-