Eighteeth

GUDID 06976117940017

Changzhou Finno Medical Technology Co., Ltd.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 06976117940017
• NIH Device Record Key: bb50fe61-e519-491b-a75d-83fcfbb2455c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eighteeth
• Version Model Number: FinScan F350
• Company DUNS: 697903063
• Company Name: Changzhou Finno Medical Technology Co., Ltd.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976117940017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242805

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: 2025-03-14
• Device Publish Date: 2025-03-06