| Primary Device ID | 00810152820810 |
| NIH Device Record Key | ca28f5df-85e3-4148-95dd-824bd918a5f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RANNIX |
| Version Model Number | 902R-WH |
| Company DUNS | 085719913 |
| Company Name | Ortho Pro Dent LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810152820810 [Primary] |
| NJM | Bracket, Ceramic, 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 | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 00810152820810 | Orthodontic Ceramic brackets with metal slot, Roth, slot .022" , Hooks on 3,4,5 |
| 00810152820803 | Orthodontic Ceramic brackets with metal slot, MBT, slot .022" , Hooks on 3,4,5 |
| 00810152820797 | Orthodontic Ceramic brackets with metal slot, MBT, slot .018" , Hooks on 3,4,5 |
| 00810152820780 | Orthodontic Ceramic brackets with metal slot, Roth, slot .018" , Hooks on 3,4,5 |