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 |