CORiTEC Splint Comfort PEMCR00016

GUDID 01111111111116

CORiTEC disc, diameter 98.5 mm, height 16 mm

pro3dure medical GmbH

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• Primary Device ID: 01111111111116
• NIH Device Record Key: 61ddf3e3-c47f-4e2d-abdf-fcfd95d98066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORiTEC Splint Comfort
• Version Model Number: clear transparent, height 16 mm
• Catalog Number: PEMCR00016
• Company DUNS: 312947842
• Company Name: pro3dure medical GmbH
• 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: true
• Expiration Date: true
• 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: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	01111111111116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212017

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [CORiTEC Splint Comfort ]

• 01111111111123: CORiTEC disc, diameter 98.5 mm, height 20 mm
• 01111111111116: CORiTEC disc, diameter 98.5 mm, height 16 mm