Laser system

GUDID 17290017590056

100-120 Vac Laser system 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: 17290017590056
• NIH Device Record Key: 1d34a53e-ee1e-484f-9ed1-3eb0e0276fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser system
• Version Model Number: EXM-2001-1100
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	07290017590059 [Primary]
GS1	17290017590056 [Package]; Contains: 07290017590059; Package: Wooden Box [1 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: false

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

On-Brand Devices [Laser system]

• 17290017590056: 100-120 Vac Laser system For Infra Inguinal Atherectomy
• 17290017590049: 200-240 Vac Laser system For Infra Inguinal Atherectomy