Auryon Laser System 100-120 Vac

Basic Information

• Brand Name: Auryon Laser System 100-120 Vac
• Primary DI: 07290017590110
• Version / Model: EXM-2001-1100
• Catalog Number: EXM-2001-1100
• Company Name: EXIMO MEDICAL LTD
• Labeler DUNS: 600468941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-20
• Public Version: 3
• Public Version Date: 2022-12-09
• Public Version Status: Update
• Public Device Record Key: e324682e-3c0b-4eaf-a88d-016680281f58

Device Description

Auryon Laser System 100-120 Vac

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	870.4875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43229	Atherectomy laser system beam guide-catheter, peripheral	A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017590110	GS1
Package	17290017590131	GS1	Crate	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181642	000
K221077	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal