Auryon Atherectomy Catheter EXM-4010-0000

GUDID 07290017590301

Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW

EXIMO MEDICAL LTD

Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: 07290017590301
• NIH Device Record Key: 9c5bc34b-e12e-43b3-87da-08d8a3992385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auryon Atherectomy Catheter
• Version Model Number: EXM-4010-0000
• Catalog Number: EXM-4010-0000
• Company DUNS: 600468941
• Company Name: EXIMO MEDICAL LTD
• 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: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com
• Phone: (518) 795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Outer Diameter: 1.5 Millimeter
• Length: 225 Centimeter
• Lumen/Inner Diameter: 0.014 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017590301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233668

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-05
• Device Publish Date: 2023-12-28

On-Brand Devices [Auryon Atherectomy Catheter]

• 07290017590172: Catheter Eximo Atherectomy 2.35mm - Hydrophilic Coated
• 07290017590165: Catheter Eximo Atherectomy 2mm - Hydrophilic Coated
• 07290017590158: Catheter Eximo Atherectomy 0.9mm - Hydrophilic Coated
• 07290017590141: Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated
• 07290017590318: Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW
• 07290017590301: Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW
• 07290017590295: Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating
• 07290017590288: Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW - Hydrophilic Coating
• 07290017590332: Auryon Atherectomy Catheter 1.7mm OTW
• 07290017590325: Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated