Catalog Number

319

Brand Name

CorPath GRX Cassette Duo

Version/Model Number

319

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

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

K221464,K221464

Product Code

DXX

Product Code Name

System, Catheter Control, Steerable

Public Device Record Key

f6b1fc39-ff13-471d-b677-91da2b654d16

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

August 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-