CorPath GRX Extended Reach Arm 312

GUDID 00816280023123

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 ID: 00816280023123
• NIH Device Record Key: 7980eb38-9329-49cc-bb4f-bdddab523936
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorPath GRX Extended Reach Arm
• Version Model Number: 312
• Catalog Number: 312
• 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: 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: XX@XX.XX
• Phone: +1-800-888-7436
• Email: XX@XX.XX
• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
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• Phone: +1-800-888-7436
• Email: XX@XX.XX
• Phone: +1-800-888-7436
• Email: XX@XX.XX
• Phone: +1-800-888-7436
• Email: contact@siemens-healthineers.com
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• Phone: +1-800-888-7436
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• 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
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• 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
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Operating and Storage Conditions

• 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
• 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	00816280023123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180517

FDA Product Code

• DXX: System, Catheter Control, Steerable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-05

On-Brand Devices [CorPath GRX Extended Reach Arm]

• 00816280023123: 312
• 00816280023024: 302