Ulthera System Control Unit

GUDID 00840763100247

ULTHERA, INC.

Ultrasonic body contouring system

• Primary Device ID: 00840763100247
• NIH Device Record Key: e814cc7a-a380-4ed9-b46d-93238354fd8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulthera System Control Unit
• Version Model Number: UC-1 Rev. K
• 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	00840763100247 [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: 2016-09-07

On-Brand Devices [Ulthera System Control Unit]

• 00840763100902: UC-1 Rev R
• 00840763100254: UC-1 Rev. L
• 00840763100247: UC-1 Rev. K
• 00840763100230: UC-1 Rev. J
• 00840763100223: UC-1 Rev. I
• 00840763100216: UC-1 Rev. H
• 00840763100209: UC-1 Rev. G
• 00840763100193: UC-1 Rev. F
• 00840763100186: UC-1 Rev. E
• 00840763100179: UC-1 Rev. D
• 00840763100162: UC-1 Rev. C
• 00840763100155: UC-1 Rev. B
• 00840763100001: UC-1 Rev. A