Nu Seal 0914

GUDID B77209140

Nu Seal - 4 Syringe Kit

NU RADIANCE INC

Dental composite resin

• Primary Device ID: B77209140
• NIH Device Record Key: 6485ed0f-3b69-453d-8ba1-3dee74dc73b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nu Seal
• Version Model Number: 4 Syringe Kit
• Catalog Number: 0914
• Company DUNS: 148149243
• Company Name: NU RADIANCE INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8668993207
• Email: info@nuradiance.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B77209140 [Primary]

FDA Product Code

• LBH: Varnish, Cavity

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: 2019-04-25
• Device Publish Date: 2019-04-17

On-Brand Devices [Nu Seal]

• B77209140: Nu Seal - 4 Syringe Kit
• B77209070: Nu Seal - 1 Syringe Kit