Accent Elite Bipolar HP AAAE21111001

GUDID 17290110120112

ALMA LASERS LTD.

Ultrasonic hyperthermia system

• Primary Device ID: 17290110120112
• NIH Device Record Key: 8486a0c4-7282-403b-beda-249706179d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accent Elite Bipolar HP
• Version Model Number: 1
• Catalog Number: AAAE21111001
• 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	17290110120112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101147

FDA Product Code

• NUV: Massager, Vacuum, Light Induced Heating

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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