| Primary Device ID | D8199015512 |
| NIH Device Record Key | bb794dd4-0c1d-4b42-8a64-a1da76bdd5c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Printed Lower ROC Pack for Herbst LR5 8mm |
| Version Model Number | 901551 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8199015510 [Primary] |
| HIBCC | D8199015512 [Package] Contains: D8199015510 Package: [5 Units] In Commercial Distribution |
| ECN | Clamp, Wire, 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 | 2025-04-11 |
| Device Publish Date | 2025-04-03 |
| D8199015462 - Printed Upper Crown Pack for Herbst UL5 | 2025-04-11 |
| D8199015472 - Printed Upper Crown Pack for Herbst UL6 | 2025-04-11 |
| D8199015482 - Printed Upper Crown Pack for Herbst UL7 | 2025-04-11 |
| D8199015492 - Printed Upper Crown Pack for Herbst UL8 | 2025-04-11 |
| D8199015502 - Printed Lower ROC Pack for Herbst LR4 8mm | 2025-04-11 |
| D8199015512 - Printed Lower ROC Pack for Herbst LR5 8mm | 2025-04-11 |
| D8199015512 - Printed Lower ROC Pack for Herbst LR5 8mm | 2025-04-11 |
| D8199015522 - Printed Lower ROC Pack for Herbst LR6 8mm | 2025-04-11 |
| D8199015532 - Printed Lower ROC Pack for Herbst LR7 8mm | 2025-04-11 |