Planmeca Romexis 10041546

GUDID 06430035420599

Planmeca Romexis is a modular imaging software for dental and medical use.

Planmeca Oy

Panoramic/tomographic dental x-ray system application software

• Primary Device ID: 06430035420599
• NIH Device Record Key: 82def1a7-f6d8-4657-b02d-1ce2d1395388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmeca Romexis
• Version Model Number: 6
• Catalog Number: 10041546
• Company DUNS: 368788568
• Company Name: Planmeca Oy
• 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: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035420599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200572

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [Planmeca Romexis]

• 06430035420254: Planmeca Romexis is a modular imaging software for dental and medical use,
• 06430035420599: Planmeca Romexis is a modular imaging software for dental and medical use.