| Primary Device ID | 00864551000304 |
| NIH Device Record Key | 8e45680f-4bce-448e-8a08-6f078081cd0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GuidePro3D |
| Version Model Number | 1.0 |
| Company DUNS | 080465734 |
| Company Name | GuidePro3D |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 8444843377 |
| jthompson@guidepro3d.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00864551000304 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GUIDEPRO3D 86728086 5200692 Live/Registered |
FPJ Enterprises LLC 2015-08-18 |