| Primary Device ID | 00850044140015 |
| NIH Device Record Key | 99a183d5-2967-4f0f-ad1c-f8d89da85986 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helo Thrombectomy System |
| Version Model Number | HEL1595 |
| Company DUNS | 117560059 |
| Company Name | Endovascular Engineering, 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 | 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 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |