PreXion3D Explorer PRO

GUDID 04589557760040

PREXION CORPORATION

Cone beam computed tomography system, head/neck
Primary Device ID04589557760040
NIH Device Record Key8c6f9b42-7982-4460-99e8-fc717ba0ada9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreXion3D Explorer PRO
Version Model NumberP03A
Company DUNS712093244
Company NamePREXION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104589557760040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-06
Device Publish Date2022-06-28

Devices Manufactured by PREXION CORPORATION

04589557760071 - PreXion3D Expedition2024-05-28
04589557760057 - PreXion3D Expedition2023-03-08
04589557760040 - PreXion3D Explorer PRO2022-07-06
04589557760040 - PreXion3D Explorer PRO2022-07-06
04589557760019 - PreXion3D Excelsior2018-10-18

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