| Primary Device ID | D8199006372 |
| NIH Device Record Key | cc0bb275-8d29-44e0-8741-377199dd1a1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Upper ROC Pack for Herbst UL5 |
| Version Model Number | 900637 |
| 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 | D8199006370 [Primary] |
| HIBCC | D8199006372 [Package] Contains: D8199006370 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 | 2023-11-07 |
| Device Publish Date | 2023-10-30 |
| D8199006250 - Upper ROC Kit for Herbst | 2024-04-30 |
| D8199006260 - Lower ROC Kit for Herbst | 2024-04-30 |
| D8199006270 - Upper Crown Kit for Herbst | 2024-04-30 |
| D8199006280 - Lower Crown Kit for Herbst | 2024-04-30 |
| D8199006290 - ROC Kit | 2024-04-30 |
| D8199006300 - Crown Kit | 2024-04-30 |
| D8199013170 - OnBrace Kit | 2024-04-30 |
| D8199013182 - OnBrace Crown UR2 (5/pk) | 2024-03-18 |