Cellfina Motor Module Device and Package

GUDID 00840763100544

EU part should not have been registered with GUDID

ULTHERA, INC.

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• Primary Device ID: 00840763100544
• NIH Device Record Key: be69ab63-cb5f-481c-b00c-6a4b10ff6bc8
• Commercial Distribution Discontinuation: 2016-09-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cellfina Motor Module Device and Package
• Version Model Number: CM1-EU Rev A
• 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	00840763100544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153677

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

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