Magellan™ ML95

GUDID 00815671020239

Magellan Robotic Catheter 6Fr & eKit Leader 95cm

HANSEN MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00815671020239
• NIH Device Record Key: 1989da62-62f0-4ad6-b8f0-fc22ee94e48a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magellan™
• Version Model Number: ML95
• Catalog Number: ML95
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Phone: 1-650-404-5844
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815671020239 [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: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Magellan™]

• 00815671020321: Magellan Robotic System 120V
• 00815671020314: Magellan Transport System
• 00815671020284: Magellan Robotic System 120V
• 00815671020239: Magellan Robotic Catheter 6Fr & eKit Leader 95cm
• 00815671020222: Magellan Robotic Catheter 6Fr & eKit Leader 60cm
• 00815671020215: Magellan Robotic Catheter eKit Accessory Kit 95cm
• 00815671020208: Magellan Robotic Catheter eKit Accessory Kit 60cm
• 00815671020192: Magellan Robotic Catheter eKit 6Fr Guide 95cm
• 00815671020185: Magellan eKit 6Fr Guide 60cm
• 00815671020178: Magellan Robotic Catheter 10Fr 80cm
• 00815671020161: Magellan Robotic Catheter 10Fr 65cm
• 00815671020154: Magellan Robotic Catheter 10Fr 50cm
• 00815671020147: Magellan Robotic Catheter 6Fr Accessory Kit 95cm
• 00815671020130: Magellan Robotic Catheter 6Fr Accessory Kit 60cm
• 00815671020123: Magellan Robotic Catheter 6Fr Guide 95cm
• 00815671020116: Magellan Robotic Catheter 6Fr Guide 60cm
• 00815671020079: Magellan Robotic Catheter 9Fr & 10Fr Caddy
• 00815671020062: Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 80cm
• 00815671020055: Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 65cm
• 00815671020048: Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 50cm
• 00815671020031: Magellan Robotic Catheter 9Fr 80cm
• 00815671020024: Magellan Robotic Catheter 9Fr 65cm
• 00815671020017: Magellan Robotic Catheter 9Fr 50cm