CorPath GRX Drive Gear 307

GUDID 00816280023079

CORINDUS, INC.

Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation Cardiac mapping system workstation
Primary Device ID00816280023079
NIH Device Record Key3f063b3e-9747-43ca-9f23-85aeea498263
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorPath GRX Drive Gear
Version Model Number307
Catalog Number307
Company DUNS781746586
Company NameCORINDUS, INC.
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone508-653-3335
Emailcustomer.service@corindus.com
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
EmailXX@XX.XX
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com
Phone+1-800-888-7436
Emailcontact@siemens-healthineers.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816280023062 [Unit of Use]
GS100816280023079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXXSystem, Catheter Control, Steerable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-20

Devices Manufactured by CORINDUS, INC.

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00816280022010 - CorPath 200 Control Console2019-09-11
00816280022027 - CorPath 200 Articulated Arm2019-09-11
00816280022034 - CorPath 200 Robotic Drive2019-09-11
00816280022041 - CorPath 200 Cassette2019-09-11
00816280022072 - CorPath 200 POGO Pin Caps2019-09-11
00816280022096 - CorPath 200 Control Console Drape2019-09-11
00816280022119 - CorPath 200 Joystick Covers2019-09-11

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