Auryon Atherectomy Catheter 2.0 mm OTW EXM-4003-0000

GUDID 07290017590080

Auryon Atherectomy Catheter 2.0 mm OTW

EXIMO MEDICAL LTD

Atherectomy laser system beam guide-catheter, peripheral
Primary Device ID07290017590080
NIH Device Record Key2aa999fa-703c-4184-945b-946c85cbf8df
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuryon Atherectomy Catheter 2.0 mm OTW
Version Model NumberEXM-4003-0000
Catalog NumberEXM-4003-0000
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 Batchfalse
Serial Numbertrue
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

Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com
Phone(518) 795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 Centimeter
Lumen/Inner Diameter0.014 Inch
Outer Diameter2.04 Millimeter
Length135 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
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
GS107290017590080 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-08-24
Device Publish Date2020-05-20

Devices Manufactured by EXIMO MEDICAL LTD

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07290017590332 - Auryon Atherectomy Catheter2024-09-24 Auryon Atherectomy Catheter 1.7mm OTW
07290017590288 - Auryon Atherectomy Catheter2024-01-05 Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW - Hydrophilic Coating
07290017590295 - Auryon Atherectomy Catheter2024-01-05 Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating
07290017590301 - Auryon Atherectomy Catheter2024-01-05 Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW
07290017590318 - Auryon Atherectomy Catheter2024-01-05 Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW
07290017590110 - Auryon Laser System 100-120 Vac2022-12-09 Auryon Laser System 100-120 Vac
07290017590141 - Auryon Atherectomy Catheter2022-10-12 Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated
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