CorPath 200 Cassette 160-00173-NC

GUDID 00816280022041

CORINDUS, INC.

Cardiac mapping system workstation
Primary Device ID00816280022041
NIH Device Record Keyf72f3762-102a-490c-a8c7-b8c296b59101
Commercial Distribution Discontinuation2019-09-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCorPath 200 Cassette
Version Model Number160-00173-NC
Catalog Number160-00173-NC
Company DUNS781746586
Company NameCORINDUS, INC.
Device Count1
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816280022041 [Primary]

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 Date2019-09-11
Device Publish Date2016-09-24

Devices Manufactured by CORINDUS, INC.

00816280023185 - CorPath GRX Cassette Duo2022-08-16
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
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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