| Primary Device ID | 00817395021813 |
| NIH Device Record Key | 1e7d1e15-2b76-46db-a1b4-a330911a8e2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wellstar Craniotomy |
| Version Model Number | WS200 |
| Company DUNS | 015179820 |
| Company Name | PACKROOM LLC |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |