Duet 0622

GUDID B77206220

Nu Radiance Duet Teeth Whitening, Patient Kit

NU RADIANCE INC

Teeth whitening kit

• Primary Device ID: B77206220
• NIH Device Record Key: 7475a695-d550-4b9b-9fe3-1d5c20c1be4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duet
• Version Model Number: Patient Kit
• Catalog Number: 0622
• Company DUNS: 148149243
• Company Name: NU RADIANCE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B77206220 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-24
• Device Publish Date: 2021-08-16

On-Brand Devices [Duet]

• B77206530: Nu Radiance Duet Teeth Whitening, 36 Syringe Bulk Pack
• B77206220: Nu Radiance Duet Teeth Whitening, Patient Kit
• B72206480: Nu Radiance Duet Teeth Whitening, Eight Syringe Pack
• B72206150: Nu Radiance Duet Teeth Whitening, Maintenance Kit