PreXion3D Expedition

GUDID 04589557760057

PREXION CORPORATION

Cone beam computed tomography system, head/neck

• Primary Device ID: 04589557760057
• NIH Device Record Key: 93915064-717d-465b-989c-7546d49589d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreXion3D Expedition
• Version Model Number: P04A
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589557760057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222150

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [PreXion3D Expedition]

• 04589557760057: P04A
• 04589557760071: P04B