| Primary Device ID | D82813306010 |
| NIH Device Record Key | 07963cd9-7bd0-4dfa-8b69-6ec4dc78a03e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEL ETCH 9GM S/C |
| Version Model Number | 1330601 |
| Company DUNS | 113352686 |
| Company Name | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |