Focus 900986

GUDID 06430035872695

PaloDEx Group Oy

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 06430035872695
• NIH Device Record Key: 64f58edc-21c1-40d3-b5c9-234083173c6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focus
• Version Model Number: Focus
• Catalog Number: 900986
• 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	06430035872695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001729

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2017-02-17

On-Brand Devices [Focus]

• 06430035872695: Focus
• 06430035872459: Focus