FDA.reportPublic FDA data

CorPath GRX Cassette Duo

Primary DI
00816280023192
Brand
CorPath GRX Cassette Duo
Company
Corindus, Inc.
Model
319
Catalog number
319
Published
2022-08-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXXSystem, Catheter Control, SteerableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816280023192PrimaryGS10
00816280023185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816280023192008162800231928162800231920816280023192
00816280023185008162800231858162800231850816280023185

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system workstationA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1-800-888-7436contact@siemens-healthineers.com

Regulatory Flags#

DUNS number
781746586
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816280021013CorPath Interventional Cockpit1011012016-11-16
00816280021037Powervision Imaging System1031032017-01-25
00816280021044Powervision Imaging System1041042017-01-25
00816280021051CorPath Imaging System1051052017-01-25
00816280021068CorPath Imaging System1061062017-01-25
00816280023017CorPath GRX Control Console3013012017-01-20
00816280023024CorPath GRX Extended Reach Arm3023022017-01-20
00816280023031CorPath GRX Robotic Drive3033032017-01-20
00816280023055CorPath GRX Cassette3053052017-01-20
00816280023079CorPath GRX Drive Gear3073072017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and Arm3093092017-01-20
00816280023116CorPath GRX Drape, Control Console3113112017-01-20
00816280023123CorPath GRX Extended Reach Arm3123122018-04-05
00816280021020Powervision Imaging System1021022017-01-25
00816280022010CorPath 200 Control Console160-00043160-000432016-09-24
00816280022027CorPath 200 Articulated Arm160-00807160-008072016-09-24
00816280022034CorPath 200 Robotic Drive160-00050160-000502016-09-24
00816280022041CorPath 200 Cassette160-00173-NC160-00173-NC2016-09-24
00816280022072CorPath 200 POGO Pin Caps160-00876160-008762016-09-24
00816280022096CorPath 200 Control Console Drape160-00981160-009812016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M58800101400010GenesisXStereotaxis, Inc.DXX2026-01-09
07290019564003LIBERTY Endovascular Robotic SystemMICROBOT MEDICAL LTDDXX2025-11-18
07290019564058LIBERTY Endovascular Robotic System - robotMICROBOT MEDICAL LTDDXX2025-11-18
07290019564102LIBERTY Endovascular Robotic System - armMICROBOT MEDICAL LTDDXX2025-11-18
00816280023185CorPath GRX Cassette DuoCORINDUS, INC.DXX2022-08-08
00816280023123CorPath GRX Extended Reach ArmCorindus, Inc.DXX2018-04-05
00816280023017CorPath GRX Control ConsoleCorindus, Inc.DXX2017-01-20
00816280023024CorPath GRX Extended Reach ArmCorindus, Inc.DXX2017-01-20
00816280023031CorPath GRX Robotic DriveCorindus, Inc.DXX2017-01-20
00816280023055CorPath GRX CassetteCorindus, Inc.DXX2017-01-20
00816280023079CorPath GRX Drive GearCorindus, Inc.DXX2017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and ArmCorindus, Inc.DXX2017-01-20
00816280023116CorPath GRX Drape, Control ConsoleCorindus, Inc.DXX2017-01-20
00815671020246Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020260Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020284Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020314Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020321Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00816280022010CorPath 200 Control ConsoleCorindus, Inc.DXX2016-09-24
00816280022027CorPath 200 Articulated ArmCorindus, Inc.DXX2016-09-24
00816280022034CorPath 200 Robotic DriveCorindus, Inc.DXX2016-09-24
00816280022041CorPath 200 CassetteCorindus, Inc.DXX2016-09-24
00816280022072CorPath 200 POGO Pin CapsCorindus, Inc.DXX2016-09-24
00816280022096CorPath 200 Control Console DrapeCorindus, Inc.DXX2016-09-24
00816280022119CorPath 200 Joystick CoversCorindus, Inc.DXX2016-09-24
00816280022133CorPath 200 Robotic Drive DrapeCorindus, Inc.DXX2016-09-24
10815671020007Artisan®HANSEN MEDICAL, INC.DXX2016-09-23
10815671020083Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020048Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020055Magellan™HANSEN MEDICAL, INC.DXX2016-09-23