PreXion3D Excelsior

GUDID 04589557760019

PREXION CORPORATION

Limited-view-field CT system
Primary Device ID04589557760019
NIH Device Record Keyd47251e4-1981-4386-9761-473206b5f014
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreXion3D Excelsior
Version Model NumberPreXion3D Excelsior
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-212-0314
Emailkhuang@prexion.com

Device Dimensions

Height2220 Millimeter
Depth1563 Millimeter
Width1158 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104589557760019 [Primary]

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-18
Device Publish Date2016-12-31

Devices Manufactured by PREXION CORPORATION

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

Trademark Results [PreXion3D Excelsior]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREXION3D EXCELSIOR
PREXION3D EXCELSIOR
87196223 5278056 Live/Registered
PREXION CORPORATION
2016-10-07

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