0.9 mm OTW B-Laser™ catheter

GUDID 17290017590018

0.9 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy

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
Primary Device ID17290017590018
NIH Device Record Key82ef8446-a63e-495d-acf5-5b0c528efe7c
Commercial Distribution StatusIn Commercial Distribution
Brand Name0.9 mm OTW B-Laser™ catheter
Version Model NumberEXM-4002-0000
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com
Phone1-480-213-8499
Emailroberts@eximomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017590011 [Primary]
GS117290017590018 [Package]
Contains: 07290017590011
Package: Master Carton Box [11 Units]
In Commercial Distribution

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 Date2019-04-01
Device Publish Date2019-03-22

Devices Manufactured by EXIMO MEDICAL LTD

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
07290017590158 - Auryon Atherectomy Catheter2022-10-12 Catheter Eximo Atherectomy 0.9mm - Hydrophilic Coated
07290017590165 - Auryon Atherectomy Catheter2022-10-12 Catheter Eximo Atherectomy 2mm - Hydrophilic Coated

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