| Primary Device ID | 05050474755116 |
| NIH Device Record Key | c90ec084-3d41-4eb6-ab98-b9b6a373ac1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEALON DUET PRO II |
| Version Model Number | 10300016 |
| Catalog Number | 10300016 |
| Company DUNS | 103021940 |
| Company Name | JOHNSON & JOHNSON SURGICAL VISION, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |