Ulthera System Control Unit PRIME

GUDID 00840763101145

ULTHERA, INC.

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.

• 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
• 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