| Primary Device ID | 00813830023381 |
| NIH Device Record Key | 6112b547-20c9-4d25-be17-3d21ce92d1bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digital Ultra Package B, International |
| Version Model Number | 56100-INT |
| Catalog Number | 56100-INT |
| Company DUNS | 088302096 |
| Company Name | ACCUTRON, 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |