Alma VascuLife Diode System 1470 110V AADS03021302

GUDID 17290110121300

ALMA LASERS LTD.

General/multiple surgical diode laser system

• Primary Device ID: 17290110121300
• NIH Device Record Key: ad3bb72d-ddcb-49b6-8144-38c2c0ecd831
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alma VascuLife Diode System 1470 110V
• Version Model Number: 1
• Catalog Number: AADS03021302
• Company DUNS: 532283264
• Company Name: ALMA LASERS 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290110121300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140005

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2016-09-24

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