Cellfina System Disposable Tray

GUDID 00840763100094

ULTHERA, INC.

Mechanical skin contouring system injection/transection set

• Primary Device ID: 00840763100094
• NIH Device Record Key: e868aa1e-3e77-45ed-a905-880aec9d42f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellfina System Disposable Tray
• Version Model Number: CK1 Rev. F
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00840763100094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134010

FDA Product Code

• OUP: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Sterilization

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

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 [Cellfina System Disposable Tray]

• 00840763100766: CK1 rev M
• 00840763100612: CK1 Rev K
• 00840763100520: CK1 rev E
• 00840763100414: CK1 Rev J
• 00840763100407: CK1 Rev. I
• 00840763100391: CK1 Rev. G
• 00840763100094: CK1 Rev. F