| Primary Device ID | 18050038830109 |
| NIH Device Record Key | 5b76606c-6953-4538-9564-e89d65ee6e25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical guide sleeve |
| Version Model Number | 3DM00670 |
| Company DUNS | 857172105 |
| Company Name | 3DIEMME SRL |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18050038830109 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-04-22 |
| Device Publish Date | 2022-12-19 |
| 08050038832144 - RealGUIDE™ Z3D KIT, Empty Tray | 2024-12-16 |
| 08050038833165 - AZURE TAPERED BONE LEVEL GUIDED SURGICAL TRAY, EMPTY | 2024-12-16 |
| 18050038833094 - RealGUIDE Sleeve | 2024-06-06 |
| 18050038833100 - RealGUIDE Sleeve | 2024-06-06 |
| 18050038833117 - RealGUIDE Sleeve | 2024-06-06 |
| 18050038830192 - RealGUIDE Sleeve | 2024-05-02 |
| 18050038830208 - RealGUIDE Sleeve | 2024-05-02 |
| 18050038830222 - RealGUIDE Sleeve | 2024-05-02 |