Ulthera System Cart

GUDID 00840763101169

Ulthera, Inc.

Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley Electromechanical device/system transport trolley

• Primary Device ID: 00840763101169
• NIH Device Record Key: cfde87c3-7469-4c57-88b9-87d07d3e13a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulthera System Cart
• Version Model Number: UR-1 Rev. A
• Company DUNS: 010981554
• Company Name: Ulthera, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00840763101169 [Primary]

FDA Product Code

• FWY: Table, Operating-Room, Non-Electrical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-29
• Device Publish Date: 2024-05-21

Devices Manufactured by Ulthera, Inc.

• 00840763101169 - Ulthera System Cart: 2024-05-29
• 00840763101169 - Ulthera System Cart: 2024-05-29
• 10840763100107 - Cellfina System Procedure Kit (Single Package): 2024-05-09
• 00840763101145 - Ulthera System Control Unit PRIME: 2024-04-18
• 00840763101152 - Ulthera System Handpiece: 2024-04-16
• 00840763100742 - Cellfina Motor Module Device and Package: 2020-02-03
• 00840763100025 - Ulthera System Transducer DS 7-3.0: 2019-07-26
• 00840763100414 - Cellfina System Disposable Tray: 2019-07-26
• 00840763100520 - Cellfina System Disposable Tray: 2019-07-26