COMEG MEDICAL TECHNOLOGIES SK101016

GUDID 03760278260045

A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENT UBIPack brings surgeons the perfect all-in-one tool for diagnosis and treatment in an office setting.

SOPRO

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 03760278260045
• NIH Device Record Key: 086813ac-bde5-4f70-94de-a88c218c68e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMEG MEDICAL TECHNOLOGIES
• Version Model Number: UBIPACK ENT SYSTEM
• Catalog Number: SK101016
• Company DUNS: 264205501
• Company Name: SOPRO
• 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: true
• 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: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760278260045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103813

FDA Product Code

• FWF: Camera, Television, Endoscopic, Without Audio

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-12-22
• Device Publish Date: 2017-12-19

On-Brand Devices [COMEG MEDICAL TECHNOLOGIES]

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• 03760278260380: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis application
• 03760278260342: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis application
• 03760278260045: A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENT UBIPack brings surgeons the per