Orthopanthomorgraph OP300 900434

GUDID 06430035872251

PaloDEx Group Oy

Limited-view-field CT system

• Primary Device ID: 06430035872251
• NIH Device Record Key: 8f546de9-a242-4437-8e1e-99ba4d1f3ad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopanthomorgraph OP300
• Version Model Number: OP300-1
• Catalog Number: 900434
• Company DUNS: 459955188
• Company Name: PaloDEx Group 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: false

Customer Support Contacts

• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035872251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133544

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Orthopanthomorgraph OP300]

• 06430035872282: OP300-1
• 06430035872275: OP300-1
• 06430035872268: OP300-1
• 06430035872251: OP300-1
• 06430035872244: OP300-1
• 06430035872213: OP300-1