| Primary Device ID | 08800070237106 |
| NIH Device Record Key | c79d9441-6de2-4a5f-a737-1e27f054f478 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZENEX EASY SURGERY KIT |
| Version Model Number | ZENIRESKIT |
| Company DUNS | 694625347 |
| Company Name | Izenimplant 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800070237106 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
[08800070237106]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-23 |
| Device Publish Date | 2025-04-15 |
| 08800070218532 | ZENESKIT |
| 08800070230589 | ZENESTKIT |
| 08800070230572 | ZENESSKIT |
| 08800070230633 | ZENESRKIT |
| 08800070233290 | ZENESATKIT |
| 08800070237106 | ZENIRESKIT |