LipoSense 25cm, 3mm Mercedes with Temp Sensor & Se AATH21051401

GUDID 17290110120808

ALMA LASERS LTD.

Ultrasonic hyperthermia system

• Primary Device ID: 17290110120808
• NIH Device Record Key: e64c1d78-e6a3-4b39-9bba-cf95302209c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LipoSense 25cm, 3mm Mercedes with Temp Sensor & Se
• Version Model Number: 1
• Catalog Number: AATH21051401
• 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	17290110120808 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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