| Primary Device ID | 08800070237380 |
| NIH Device Record Key | 0140d682-bf09-457d-9a69-558a217c0d28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZENEX Slim KIT |
| Version Model Number | ZENSLRKIT |
| 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 | 08800070237380 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
Moist Heat or Steam Sterilization
[08800070237380]
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 |
| 08800070237380 | ZENSLRKIT |
| 08800070237373 | ZENSLTKIT |
| 08800070237366 | ZENSLSKIT |
| 08800070237359 | ZENSLKIT |