PreXion3D Excelsior

GUDID 04589557760019

PREXION CORPORATION

Limited-view-field CT system

• Primary Device ID: 04589557760019
• NIH Device Record Key: d47251e4-1981-4386-9761-473206b5f014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreXion3D Excelsior
• Version Model Number: PreXion3D Excelsior
• Company DUNS: 712093244
• Company Name: PREXION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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

Customer Support Contacts

• Phone: 650-212-0314
• Email: khuang@prexion.com

Device Dimensions

• Height: 2220 Millimeter
• Depth: 1563 Millimeter
• Width: 1158 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589557760019 [Primary]

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-18
• Device Publish Date: 2016-12-31

Devices Manufactured by PREXION CORPORATION

• 04589557760057 - PreXion3D Expedition: 2023-03-08
• 04589557760040 - PreXion3D Explorer PRO: 2022-07-06
• 04589557760019 - PreXion3D Excelsior: 2018-10-18
• 04589557760019 - PreXion3D Excelsior: 2018-10-18