| Primary Device ID | 08800070229682 |
| NIH Device Record Key | 97efd53b-0db9-40f7-bd84-35be69cc06da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZENEX PLUS Fixture Set |
| Version Model Number | ZPSW5513S |
| Company DUNS | 694625347 |
| Company Name | Izenimplant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |