| Primary Device ID | D8199015742 |
| NIH Device Record Key | f9fe9f01-53b5-4fbf-9c1b-6c2a341040fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Printed Lower ROC Pack for Herbst LL8 8mm |
| Version Model Number | 901574 |
| 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 |