CorPath GRX Extended Reach Arm 302

GUDID 00816280023024

CORINDUS, INC.

Cardiac mapping system workstation

• Primary Device ID: 00816280023024
• NIH Device Record Key: 7c086c14-b4a1-4d3e-93b1-a405055c2e24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorPath GRX Extended Reach Arm
• Version Model Number: 302
• Catalog Number: 302
• Company DUNS: 781746586
• Company Name: CORINDUS, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: 508-653-3335
• Email: customer.service@corindus.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816280023024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160121

FDA Product Code

• DXX: System, Catheter Control, Steerable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-20

On-Brand Devices [CorPath GRX Extended Reach Arm]

• 00816280023123: 312
• 00816280023024: 302