NuFACE

Basic Information

• Brand Name: NuFACE
• Primary DI: 00856349005639
• Version / Model: 40280
• Company Name: Nuface
• Labeler DUNS: 023980008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fbd1bc52-c229-468f-adb4-7bffb0deead0

Device Description

Refreshed TWR Attachment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
45687	Red-light phototherapy unit, battery-powered	A battery-powered device designed to emit a low-level narrow-band (LLNB) red light in the visible wavelength around 630 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds. This is a hand-held device that may be operated by the patient/user and is suitable for home-use. It may be used to help treat intraoral, nasal, or dermal conditions such as oral ulcers, gingival inflammation, bad breath, allergic rhinitis (hay fever), or nasal congestion.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856349005639	GS1