| Primary Device ID | 08056646508761 |
| NIH Device Record Key | acd8e711-2170-498a-81b9-fd44590255a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnisleeve |
| Version Model Number | 22.U0005.00 |
| Company DUNS | 447696675 |
| Company Name | OMNIA SRL |
| Device Count | 10 |
| DM Exempt | false |
| 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 | false |
| 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 |