| Primary Device ID | 08809918259980 |
| NIH Device Record Key | 9b93f51c-a632-49a0-8936-89b3a9408512 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Option Kit |
| Version Model Number | SGK |
| Company DUNS | 695365503 |
| Company Name | Ossvis 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 | 08809918259980 [Primary] |
| OFY | Dental Implant Surgical Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
[08809918259980]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-05 |
| Device Publish Date | 2025-02-25 |
| 08809918259997 - LL Driver Separator | 2025-12-23 Dental Implant Surgical Instrument - Driver Separator |
| 08809918274037 - Guide Full Flattening Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |
| 08809918274044 - Guide Full Lindemann Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |
| 08809918274051 - Guide Full Lindemann Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |
| 08809918274068 - Guide Full Lindemann Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |
| 08809918274075 - Guide Full Lindemann Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |
| 08809918274082 - Guide Full Lindemann Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |
| 08809918274099 - Guide Full Cortical Drill | 2025-12-23 Dental Implant Surgical Instrument - Drill |