| Primary Device ID | 14719874742222 |
| NIH Device Record Key | f023112f-a21b-470f-a077-c7bc26eb51d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LensHooke Sperm Separation Device |
| Version Model Number | CA1 Package-25 sets-US-HT |
| Catalog Number | CA1 |
| Company DUNS | 658872369 |
| Company Name | BONRAYBIO CO., LTD. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14719874742222 [Primary] |
| MQK | Labware, Assisted Reproduction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-24 |
| Device Publish Date | 2025-02-16 |
| 04719874741242 - LensHooke Liquefaction Enzyme | 2025-02-24 |
| 04719874741303 - LensHooke Semen Quality Analyzer | 2025-02-24 |
| 04719874742652 - LensHooke X QC Slide (For Semen) | 2025-02-24 |
| 14719874740747 - LensHooke Cleaning Wipe | 2025-02-24 |
| 14719874740808 - LensHooke Cleaning Wipe | 2025-02-24 |
| 14719874742222 - LensHooke Sperm Separation Device | 2025-02-24 |
| 14719874742222 - LensHooke Sperm Separation Device | 2025-02-24 |
| 14719874742239 - LensHooke Sperm Separation Device | 2025-02-24 |
| 14719874742253 - LensHooke Sperm Separation Device | 2025-02-24 |