COMEG MEDICAL S_281_0002

GUDID M430S28100021

"This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following special fields: ent, gynecology, urology, veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal protection system and a power level memory."

SOPRO

Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered

• Primary Device ID: M430S28100021
• NIH Device Record Key: 7d69e6fa-e7c0-4d7b-a817-832616a6a01c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMEG MEDICAL
• Version Model Number: SOURCE LED SOPRO 281 BLANC
• Catalog Number: S_281_0002
• 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: 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: +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
HIBCC	M430S28100021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103813

FDA Product Code

• NTN: Led Light Source

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: 2016-09-24

On-Brand Devices [COMEG MEDICAL]

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• M430S28100021: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis application
• M430S28100011: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis application
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• M430S23000091: Xenon light source 300 Watts, US Power Cord - Olympus adapter
• M430S23000051: Xenon light source 300 Watts, US Power Cord - Storz adapter
• M430S21800121: Xenon light source 180 Watts, US Power Cord - Wolf adapter
• M430S21800111: Xenon light source 180 Watts, US Power Cord - Olympus adapter
• M430S21800091: Xenon light source 180 Watts, US Power Cord - Olympus adapter
• M430S21800061: Xenon light source 180 Watts, US Power Cord - Storz adapter
• 03760278260427: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis application