| Primary Device ID | G290V2627 |
| NIH Device Record Key | 4d325ab5-c355-41bd-a134-4bdf982d6048 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shell, Scleral |
| Version Model Number | V2627 |
| Company DUNS | 809338473 |
| Company Name | Midwest Eye Laboratories Woodbury, LLC |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit |