UltraShape system FG71051USR

GUDID 07290109951782

UltraShape System, Packaged for US

SYNERON MEDICAL LTD

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• Primary Device ID: 07290109951782
• NIH Device Record Key: 10d11a94-cdea-4ab5-92af-e36ab8301d54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraShape system
• Version Model Number: FG71051USR
• Catalog Number: FG71051USR
• 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	07290109951782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141708

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: 2016-09-25

On-Brand Devices [UltraShape system]

• 07290109951782: UltraShape System, Packaged for US
• 07290109951157: UltraShape System, Packaged for US