Artisan Extend® 12412

GUDID 00815671020109

Artisan Extend Control Catheter

HANSEN MEDICAL, INC.

Cardiac ventriculography catheter

• Primary Device ID: 00815671020109
• NIH Device Record Key: 39288c14-82bb-42d9-89e5-37a122a97a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artisan Extend®
• Version Model Number: 12412
• Catalog Number: 12412
• Company DUNS: 128941304
• Company Name: HANSEN MEDICAL, 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: 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: 1-650-404-5844
• Email: xx@xx.xx
• Phone: 1-650-404-5844
• Email: xx@xx.xx
• Phone: 1-650-404-5844
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815671020109 [Primary]

FDA Product Code

• DRA: Catheter, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

Devices Manufactured by HANSEN MEDICAL, INC.

• 00815671020079 - Magellan™: 2019-08-09 Magellan Robotic Catheter 9Fr & 10Fr Caddy
• 00815671020017 - Magellan™: 2019-01-23 Magellan Robotic Catheter 9Fr 50cm
• 00815671020024 - Magellan™: 2019-01-23 Magellan Robotic Catheter 9Fr 65cm
• 00815671020031 - Magellan™: 2019-01-23 Magellan Robotic Catheter 9Fr 80cm
• 00815671020116 - Magellan™: 2019-01-23 Magellan Robotic Catheter 6Fr Guide 60cm
• 00815671020123 - Magellan™: 2019-01-23 Magellan Robotic Catheter 6Fr Guide 95cm
• 00815671020154 - Magellan™: 2019-01-23 Magellan Robotic Catheter 10Fr 50cm
• 00815671020161 - Magellan™: 2019-01-23 Magellan Robotic Catheter 10Fr 65cm