Forte 0820

GUDID B77208200

Nu Radiance Forte Teeth Whitening, Patient Kit

NU RADIANCE INC

Teeth whitening kit

• Primary Device ID: B77208200
• NIH Device Record Key: 01f22329-a7aa-4777-903e-cd3d4a109545
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forte
• Version Model Number: Patient Kit
• Catalog Number: 0820
• 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	B77208200 [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 [Forte]

• B77208530: Nu Radiance Forte Teeth Whitening, 36 Syringe Bulk Pack
• B77208200: Nu Radiance Forte Teeth Whitening, Patient Kit
• B77208150: Nu Radiance Forte Teeth Whitening, Touch Up Kit
• B77208130: Nu Radiance Forte Teeth Whitening, Maintenance Kit