Cellfina Motor Module Device and Package

GUDID 00840763100384

No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI

ULTHERA, INC.

Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor Mechanical skin contouring system motor

• Primary Device ID: 00840763100384
• NIH Device Record Key: aaa4d431-3f96-4d7f-9275-1f057e9a18f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellfina Motor Module Device and Package
• Version Model Number: CM1 Rev C, D, E
• 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	00840763100384 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-07

On-Brand Devices [Cellfina Motor Module Device and Package]

• 00840763100742: CM1 Rev G
• 00840763100568: DI mis issued - not in use
• 00840763100544: EU part should not have been registered with GUDID
• 00840763100384: No change in DI justified in the CO. No form fit function, model or version changes triggering
• 00840763100117: CM1 Rev B