Auryon Atherectomy Catheter

GUDID 07290017590141

Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated

EXIMO MEDICAL LTD

Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral
Primary Device ID07290017590141
NIH Device Record Key90631b81-72d0-43d5-aac5-2f93a70985b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuryon Atherectomy Catheter
Version Model NumberEXM-4001-H000
Company DUNS600468941
Company NameEXIMO MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com
Phone518-795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter1.5 Millimeter
Length150 Centimeter
Lumen/Inner Diameter0.014 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017590141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-12
Device Publish Date2022-10-04

On-Brand Devices [Auryon Atherectomy Catheter]

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