Ulthera System Control Unit PRIME

GUDID 00840763101145

ULTHERA, INC.

Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal Ultrasound hyperthermia system transducer, extracorporeal

• Primary Device ID: 00840763101145
• NIH Device Record Key: 65b8f012-f8da-41d7-977f-cba699342860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulthera System Control Unit PRIME
• Version Model Number: UC-1 Control Unit (PRIME) Rev. A
• Company DUNS: 010981554
• Company Name: ULTHERA, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840763101145 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-18
• Device Publish Date: 2024-04-10

Devices Manufactured by ULTHERA, INC.

• 10840763100107 - Cellfina System Procedure Kit (Single Package): 2024-05-09
• 00840763101145 - Ulthera System Control Unit PRIME: 2024-04-18
• 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
• 00840763100612 - Cellfina System Disposable Tray: 2019-07-26