CorPath GRX Drive Gear 307

GUDID 00816280023079

CORINDUS, INC.

Cardiac mapping system workstation

• Primary Device ID: 00816280023079
• NIH Device Record Key: 3f063b3e-9747-43ca-9f23-85aeea498263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorPath GRX Drive Gear
• Version Model Number: 307
• Catalog Number: 307
• Company DUNS: 781746586
• Company Name: CORINDUS, INC.
• Device Count: 4
• 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: 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
• Email: XX@XX.XX
• Phone: +1-800-888-7436
• Email: XX@XX.XX
• Phone: +1-800-888-7436
• Email: XX@XX.XX
• Phone: +1-800-888-7436
• Email: XX@XX.XX
• Phone: +1-800-888-7436
• Email: XX@XX.XX
• 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
• 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 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816280023062 [Unit of Use]
GS1	00816280023079 [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: true

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

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• 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