| Primary Device ID | 08050038833165 |
| NIH Device Record Key | d94e892b-ebf0-4829-993d-9d0edab1e97f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AZURE TAPERED BONE LEVEL GUIDED SURGICAL TRAY, EMPTY |
| Version Model Number | 3DM00632TBLTRAY |
| Company DUNS | 857172105 |
| Company Name | 3DIEMME SRL |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08050038833165 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-16 |
| Device Publish Date | 2024-12-06 |
| 08050038833226 - RealGUIDE Z3D KIT, Empty Tray | 2026-03-18 |
| 08050038834407 - RealGUIDE Z3D Surgical Kit | 2026-03-18 |
| 18050038834411 - RealGUIDE Sleeve | 2026-03-18 |
| 18050038834428 - RealGUIDE Sleeve | 2026-03-18 |
| 18050038834435 - RealGUIDE Sleeve | 2026-03-18 |
| 18050038834442 - RealGUIDE Sleeve | 2026-03-18 |
| 18050038834459 - RealGUIDE Sleeve | 2026-03-18 |
| 18050038834466 - RealGUIDE Sleeve | 2026-03-18 |