NuFACE

GUDID 00854278006864

Leave-On Gel Primer 2oz. -

Nuface

Electrode conductive medium

• Primary Device ID: 00854278006864
• NIH Device Record Key: e3466928-7803-4fa8-b2ae-565d15e9cd1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuFACE
• Version Model Number: 30410
• Company DUNS: 023980008
• Company Name: Nuface
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00854278006864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161654

FDA Product Code

• GYB: Media, Electroconductive

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: 2018-10-22
• Device Publish Date: 2018-09-05

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• 00858398007596: Trinity Kit White PRO Holiday 2018 -
• 00858398007558: Mini Kit Holiday 2018
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• 00858398007268: Mini Kit Spring 2018 "Mini PowerLIFT"-
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• 00858398007107: Mini Silver + Optimizing Mist + Black Pouch
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