CorPath 200 Robotic Drive Drape 160-00828

GUDID 00816280022133

CORINDUS, INC.

Cardiac mapping system workstation

• Primary Device ID: 00816280022133
• NIH Device Record Key: f2a65da1-abd1-459d-ab4d-ae5e73ba3c92
• Commercial Distribution Discontinuation: 2019-09-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CorPath 200 Robotic Drive Drape
• Version Model Number: 160-00828
• Catalog Number: 160-00828
• Company DUNS: 781746586
• Company Name: CORINDUS, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com
• Phone: 508-653-3335
• Email: cutomer.service@corindus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816280022126 [Unit of Use]
GS1	00816280022133 [Primary]

FDA Product Code

• DXX: System, Catheter Control, Steerable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-11
• Device Publish Date: 2016-09-24

Devices Manufactured by CORINDUS, INC.

• 00816280023185 - CorPath GRX Cassette Duo: 2022-08-16
• 00816280022010 - CorPath 200 Control Console: 2019-09-11
• 00816280022027 - CorPath 200 Articulated Arm: 2019-09-11
• 00816280022034 - CorPath 200 Robotic Drive: 2019-09-11
• 00816280022041 - CorPath 200 Cassette: 2019-09-11
• 00816280022072 - CorPath 200 POGO Pin Caps: 2019-09-11
• 00816280022096 - CorPath 200 Control Console Drape: 2019-09-11
• 00816280022119 - CorPath 200 Joystick Covers: 2019-09-11