ORTHOPANTOMOGRAPH OP 3D Pro 901004

GUDID 06430035872756

PaloDEx Group Oy

Limited-view-field CT system

• Primary Device ID: 06430035872756
• NIH Device Record Key: 2c70fd6b-f250-4dd2-ac64-56efea57e3fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOPANTOMOGRAPH OP 3D Pro
• Version Model Number: OP300-1
• Catalog Number: 901004
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035872756 [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: 2017-03-31

On-Brand Devices [ORTHOPANTOMOGRAPH OP 3D Pro]

• 06430035872770: OP300-1
• 06430035872763: OP300-1
• 06430035872756: OP300-1
• 06430035872749: OP300-1
• 06430035872732: OP300-1
• 06430035872725: OP300-1