| Primary Device ID | 08806169099495 |
| NIH Device Record Key | 09873dd5-9791-4da1-8b22-910ea2be26b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIOnavi-SG02 |
| Version Model Number | 3DCLRSG-1000 |
| Company DUNS | 631085206 |
| Company Name | DIO Corporation |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806169099495 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-22 |
| Device Publish Date | 2025-09-12 |
| 08800049245330 - Healing Cap | 2025-09-29 |
| 08800049245361 - Healing Cap | 2025-09-29 |
| 08800049245422 - Cemented Cylinder | 2025-09-29 |
| 08800049245460 - Cemented Cylinder | 2025-09-29 |
| 08800049245507 - Cemented Cylinder | 2025-09-29 |
| 08800049245545 - Cemented Cylinder | 2025-09-29 |
| 08800049416884 - Temporary Cylinder | 2025-09-29 |
| 08806169097729 - Healing Cap | 2025-09-29 |