Catalog Number

160-00981

Brand Name

CorPath 200 Control Console Drape

Version/Model Number

160-00981

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 06, 2019

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"

Yes

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

-

Product Code

DXX

Product Code Name

System, Catheter Control, Steerable

Public Device Record Key

c95e398d-9873-4ab9-baab-d05282d1c1c6

Public Version Date

October 19, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-