| Primary Device ID | B504OMMR10MH300 |
| NIH Device Record Key | c2a07848-2e57-4d5a-b90c-e997e27b4e63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omega Surgical |
| Version Model Number | MR10MH30 |
| Company DUNS | 016889401 |
| Company Name | Provision |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |