Cellfina Prep Pack

GUDID 00840763100803

ULTHERA, INC.

Mechanical skin contouring system injection/transection set

• Primary Device ID: 00840763100803
• NIH Device Record Key: b254b128-ca6d-421c-b507-1aba062e4a3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellfina Prep Pack
• Version Model Number: CP1 Rev G
• 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: 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	00840763100803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161885

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-26
• Device Publish Date: 2019-07-18

On-Brand Devices [Cellfina Prep Pack]

• 00840763100803: CP1 Rev G
• 00840763100377: CP1 Rev D
• 00840763100124: CP1 Rev C