| Primary Device ID | 00841543143805 |
| NIH Device Record Key | c72d17ce-80ed-4cea-9475-d632b2d63ddb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O'NEILL |
| Version Model Number | ONS-ENSENADA2.0-113P |
| Company DUNS | 845937478 |
| Company Name | Inspecs U.S.A., L.C. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | false |
| 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 | true |