1.5 mm OTW B-Laser™ catheter

GUDID 17290017590001

1.5 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 ID: 17290017590001
• NIH Device Record Key: ded3883c-5a30-487c-8490-b4fb7c927fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5 mm OTW B-Laser™ catheter
• Version Model Number: EXM-4001-0000
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com
• Phone: 1-480-213-8499
• Email: roberts@eximomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017590004 [Primary]
GS1	17290017590001 [Package]; Contains: 07290017590004; Package: Master Carton Box [11 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181642

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: 2019-04-01
• Device Publish Date: 2019-03-22

Devices Manufactured by EXIMO MEDICAL LTD

• 07290017590288 - Auryon Atherectomy Catheter: 2024-01-05 Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW - Hydrophilic Coating
• 07290017590295 - Auryon Atherectomy Catheter: 2024-01-05 Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating
• 07290017590301 - Auryon Atherectomy Catheter: 2024-01-05 Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW
• 07290017590318 - Auryon Atherectomy Catheter: 2024-01-05 Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW
• 07290017590110 - Auryon Laser System 100-120 Vac: 2022-12-09 Auryon Laser System 100-120 Vac
• 07290017590141 - Auryon Atherectomy Catheter: 2022-10-12 Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated
• 07290017590158 - Auryon Atherectomy Catheter: 2022-10-12 Catheter Eximo Atherectomy 0.9mm - Hydrophilic Coated
• 07290017590165 - Auryon Atherectomy Catheter: 2022-10-12 Catheter Eximo Atherectomy 2mm - Hydrophilic Coated