| Primary Device ID | 00858711006350 |
| NIH Device Record Key | 1eea52c5-7f7d-4743-b385-f311271937be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraPrene |
| Version Model Number | DDS-305 |
| Catalog Number | DDS-305 |
| Company DUNS | 018638145 |
| Company Name | AMERICAN MEDICAL & DENTAL SUPPLIES 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |