| Primary Device ID | 08050038831413 |
| NIH Device Record Key | cf7447ac-9fe4-4097-a5f9-7677e6ce0590 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Double diameter drill D2,8/2,4x13mm RealGUIDE Z3D Kit |
| Version Model Number | 3DM00613.28.130ZUS |
| 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 | 08050038831413 [Primary] |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
[08050038831413]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-04-22 |
| Device Publish Date | 2022-12-19 |
| 08050038831437 | 3DM00613.28.160ZUS |
| 08050038831413 | 3DM00613.28.130ZUS |