NuFACE

GUDID 00858398007008

Leave-On Gel Primer 10oz

Nuface

Electrode conductive medium

• Primary Device ID: 00858398007008
• NIH Device Record Key: 46da402b-2a13-480e-8a5d-e79fd02cf80d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuFACE
• Version Model Number: 30440
• 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	00858398007008 [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

On-Brand Devices [NuFACE]

• 00858398007947: Trinity Kit White PRO Spring 2019 -
• 00858398007916: Trinity Kit Platinum + ELE
• 00858398007909: Trinity Kit Blush + ELE
• 00858398007886: Trinity Kit Blush
• 00858398007862: Mini Kit Spring 2019
• 00858398007855: Trinity Spring 2019 -
• 00858398007664: Trinity + ELE Kit - Caribbean Sea
• 00858398007657: Trinity + ELE Kit - White
• 00858398007640: Trinity + ELE Kit - Petal Pink
• 00858398007626: FIX Kit
• 00858398007602: Trinity Kit White Holiday 2018 -
• 00858398007596: Trinity Kit White PRO Holiday 2018 -
• 00858398007558: Mini Kit Holiday 2018
• 00858398007527: NuBODY Demo Pack
• 00858398007268: Mini Kit Spring 2018 "Mini PowerLIFT"-
• 00858398007244: Trinity Kit White Spring 2018
• 00858398007237: Trinity Kit White PRO Spring 2018 - "PowerLIFT"
• 00858398007213: Mini Seafoam
• 00858398007206: Mini Seafoam
• 00858398007176: Trinity + ELE Kit - Pinktini
• 00858398007169: Trinity + ELE Kit - TEAL
• 00858398007152: Trinity + ELE Kit - White
• 00858398007121: Mini Pinktini + Optimizing Mist + Black Pouch
• 00858398007114: Mini White + Optimizing Mist + Black Pouch
• 00858398007107: Mini Silver + Optimizing Mist + Black Pouch
• 00858398007084: NuBODY
• 00858398007053: Mini White + Optimizing Mist
• 00858398007046: Mini Pinktini + Optimizing Mist
• 00858398007008: Leave-On Gel Primer 10oz
• 00858271002878: Trinity PRO + TWR Kit - White
• 00858271002854: Trinity Kit - Deep Pink
• 00858271002830: Trinity + ELE Kit - White
• 00858271002793: Mini Kit - White
• 00858271002625: Trinity PRO Kit - White
• 00858271002601: ELE Attachment
• 00858271002472: Trinity + TWR Kit - White
• 00858271002458: Gel Primer - 2oz
• 00858271002427: TWR Attachment
• 00858271002359: Trinity Kit Back Bar - White
• 00858271002250: Trinity Kit - White
• 00858271002083: Gel Primer - 5oz
• 00856349005653: Refreshed Mini Kit - White
• 00856349005646: Refreshed ELE Attachment
• 00856349005639: Refreshed TWR Attachment
• 00856349005417: Trinity Kit - Pinktini
• 00856349005295: Trinity PRO + ELE Kit - White
• 00856349005264: Mini Kit - Caribbean Sea
• 00856349005158: Mini + Lifter Serum Kit - White
• 00856349005011: Trinity Kit - Icicle Blue
• 00854278006901: Mini Kit Platinum On the Glow -