| Primary Device ID | D8199013942 |
| NIH Device Record Key | fcb34a37-187b-461c-976d-817559f1fdae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pedo OnBrace Crown UR1 (5/pk) |
| Version Model Number | 901394 |
| Company DUNS | 106645484 |
| Company Name | SPECIALTY APPLIANCES, 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |