| Primary Device ID | 00810118103223 |
| NIH Device Record Key | 52105c87-625e-460b-ac62-5c0510f41f6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NuSmile UCSM Replacement Band |
| Version Model Number | RB281/2 |
| Company DUNS | 185497372 |
| Company Name | NUSMILE, LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com | |
| Phone | 713.861.0033 |
| smunoz@nusmile.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810118103223 [Primary] |
| DYT | Maintainer, Space Preformed, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-01 |
| Device Publish Date | 2023-02-21 |
| 00810118103490 | NuSmile UCSM Replacement Band - Size 42 |
| 00810118103483 | NuSmile UCSM Replacement Band - Size 41 1/2 |
| 00810118103476 | NuSmile UCSM Replacement Band - Size 41 |
| 00810118103469 | NuSmile UCSM Replacement Band - Size 40 1/2 |
| 00810118103452 | NuSmile UCSM Replacement Band - Size 40 |
| 00810118103445 | NuSmile UCSM Replacement Band - Size 39 1/2 |
| 00810118103438 | NuSmile UCSM Replacement Band - Size 39 |
| 00810118103421 | NuSmile UCSM Replacement Band - Size 38 1/2 |
| 00810118103414 | NuSmile UCSM Replacement Band - Size 38 |
| 00810118103407 | NuSmile UCSM Replacement Band - Size 37 1/2 |
| 00810118103391 | NuSmile UCSM Replacement Band - Size 37 |
| 00810118103384 | NuSmile UCSM Replacement Band - Size 36 1/2 |
| 00810118103377 | NuSmile UCSM Replacement Band - Size 36 |
| 00810118103360 | NuSmile UCSM Replacement Band - Size 35 1/2 |
| 00810118103353 | NuSmile UCSM Replacement Band - Size 35 |
| 00810118103346 | NuSmile UCSM Replacement Band - Size 34 1/2 |
| 00810118103339 | NuSmile UCSM Replacement Band - Size 34 |
| 00810118103322 | NuSmile UCSM Replacement Band - Size 33 1/2 |
| 00810118103315 | NuSmile UCSM Replacement Band - Size 33 |
| 00810118103308 | NuSmile UCSM Replacement Band - Size 32 1/2 |
| 00810118103292 | NuSmile UCSM Replacement Band - Size 32 |
| 00810118103285 | NuSmile UCSM Replacement Band - Size 31 1/2 |
| 00810118103278 | NuSmile UCSM Replacement Band - Size 31 |
| 00810118103261 | NuSmile UCSM Replacement Band - Size 30 1/2 |
| 00810118103254 | NuSmile UCSM Replacement Band - Size 30 |
| 00810118103247 | NuSmile UCSM Replacement Band - Size 29 1/2 |
| 00810118103230 | NuSmile UCSM Replacement Band - Size 29 |
| 00810118103223 | NuSmile UCSM Replacement Band - Size 28 1/2 |
| 00810118103216 | NuSmile UCSM Replacement Band - Size 28 |
| 00810118103209 | NuSmile UCSM Replacement Band - Size 27 1/2 |
| 00810118103155 | NuSmile UCSM Replacement Band - Size 27 |
| 00810118103148 | NuSmile UCSM Replacement Band - Size 26 1/2 |
| 00810118103131 | NuSmile UCSM Replacement Band - Size 26 |
| 00810118103124 | NuSmile UCSM Replacement Band - Size 25 1/2 |
| 00810118103117 | NuSmile UCSM Replacement Band - Size 25 |
| 00810118103100 | NuSmile UCSM Replacement Band - Size 24 1/2 |
| 00810118103094 | NuSmile UCSM Replacement Band - Size 24 |
| 00810118103087 | NuSmile UCSM Replacement Band - Size 23 1/2 |
| 00810118103070 | NuSmile UCSM Replacement Band - Size 23 |