| Primary Device ID | B77209760 |
| NIH Device Record Key | bc64f0fa-5378-4aa6-9cad-e12c771c3a9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nu Shield |
| Version Model Number | 0.4 gram - 50 pack |
| Catalog Number | 0976 |
| 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 |
| Phone | 8668993207 |
| info@nuradiance.com | |
| Phone | 8668993207 |
| info@nuradiance.com | |
| Phone | 8668993207 |
| info@nuradiance.com | |
| Phone | 8668993207 |
| info@nuradiance.com | |
| Phone | 8668993207 |
| info@nuradiance.com | |
| Phone | 8668993207 |
| info@nuradiance.com | |
| Phone | 8668993207 |
| info@nuradiance.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B77209760 [Primary] |
| LBH | Varnish, Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-09 |
| Device Publish Date | 2021-07-30 |
| B77209740 | Nu Shield 0.4 gram Unit Dose 100 Packet |
| B77211170 | Nu Shield 0.25 gram Unit Dose 200 Packet |
| B77211000 | Nu Shield 0.4 gram Unit Dose 200 Packet |
| B77209900 | Nu Shield 0.25 gram Unit Dose 100 Packet |
| B77209760 | Nu Shield 0.4 gram Unit Dose 50 Packet |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NU SHIELD 86113658 4551747 Live/Registered |
Nu Radiance, Inc 2013-11-08 |