Planmeca Viso 30004941

GUDID 06430035420551

The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomie

Planmeca Oy

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• Primary Device ID: 06430035420551
• NIH Device Record Key: f59dcbd9-2097-469b-95c6-c5f6a79a3157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmeca Viso
• Version Model Number: G7
• Catalog Number: 30004941
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035420551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181576

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: 2018-10-22
• Device Publish Date: 2018-09-21

On-Brand Devices [Planmeca Viso]

• 06430035420605: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensi
• 06430035420551: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensi