PreXion3D Explorer PRO

GUDID 04589557760040

PREXION CORPORATION

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• Primary Device ID: 04589557760040
• NIH Device Record Key: 8c6f9b42-7982-4460-99e8-fc717ba0ada9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreXion3D Explorer PRO
• Version Model Number: P03A
• 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	04589557760040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203784

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: 2022-07-06
• Device Publish Date: 2022-06-28

Devices Manufactured by PREXION CORPORATION

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