| Primary Device ID | 00192538901024 |
| NIH Device Record Key | 120bcb98-c560-4aa9-a89c-a6e3af88c22b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Deluxe Kit |
| Version Model Number | MEN00308 |
| Company DUNS | 690680533 |
| Company Name | MENICON CO.,LTD. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192538901024 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-11 |
| Device Publish Date | 2020-05-01 |
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| 00192538901017 - Deluxe Scleral Lens Kit | 2020-05-11 |
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| 00192538901024 - Deluxe Kit | 2020-05-11 |
| 00192538901031 - Basic Scleral Lens Kit | 2020-05-11 |
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