CorPath GRX Drape, Control Console

Basic Information

• Brand Name: CorPath GRX Drape, Control Console
• Primary DI: 00816280023116
• Version / Model: 311
• Catalog Number: 311
• Company Name: Corindus, Inc.
• Labeler DUNS: 781746586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 7
• Public Version Date: 2022-10-19
• Public Version Status: Update
• Public Device Record Key: b6159bb2-2d15-40fa-b029-9a7c9edeec84

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXX	System, Catheter Control, Steerable	Cardiovascular	870.1290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31742	Cardiac mapping system workstation	A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816280023116	GS1
Unit of Use	00816280023109	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160121	000
K173288	000
K202275	000