Ulthera System Handpiece

GUDID 00840763100438

ULTHERA, INC.

Ultrasonic body contouring system

• Primary Device ID: 00840763100438
• NIH Device Record Key: 07d1d614-afeb-4887-a68b-16328e86b94d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulthera System Handpiece
• Version Model Number: UH-2 Rev. H
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840763100438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134032

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2016-12-14

On-Brand Devices [Ulthera System Handpiece]

• 00840763100919: UH-2 Rev N
• 00840763100506: UH-2 Rev. J
• 00840763100490: UH-2 Rev. I
• 00840763100483: UH-2 Rev. 1
• 00840763100438: UH-2 Rev. H
• 00840763100421: UH-2 Rev. G
• 00840763100308: UH-2 Rev. F
• 00840763100292: UH-2 Rev. E
• 00840763100285: UH-2 Rev. D
• 00840763100278: UH-2 Rev. C
• 00840763100261: UH-2 Rev. B
• 00840763100018: UH-2 Rev. A
• 00840763101152: UH-2 DS 2.0 Rev A