UltraShape Power System FG71481US

GUDID 07290109950990

UltraShape Power System, Packaged

SYNERON MEDICAL LTD

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• Primary Device ID: 07290109950990
• NIH Device Record Key: d9f218b7-500e-4ca7-b120-554fc3c85885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraShape Power System
• Version Model Number: FG71481US
• Catalog Number: FG71481US
• Company DUNS: 532685716
• Company Name: SYNERON 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: false
• 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	07290109950990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160896

FDA Product Code

• OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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: 2016-09-21

On-Brand Devices [UltraShape Power System]

• 07290109952062: UltraShape Power System, Packaged
• 07290109950990: UltraShape Power System, Packaged