| Primary Device ID | 08050038831116 |
| NIH Device Record Key | 8876fe62-4d7c-4664-843d-72e4126a2839 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RealGUIDE IMPLANT MOUNT |
| Version Model Number | 3DM00606ZIM47US |
| 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 | 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 | 08050038831116 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
[08050038831116]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-11 |
| Device Publish Date | 2022-07-01 |
| 08050038831116 | Implant mount (Zimmer TSV D4,7mm connection) - RealGUIDE Z3D Kit |
| 08050038831109 | Implant mount (Zimmer TSV D3,7/4,1mm connection) - RealGUIDE Z3D Kit |
| 08050038831093 | Implant mount (Zimmer Eztetic D3,1mm connection) - RealGUIDE Z3D Kit |