MegaBeam ENT-20-US-IC

GUDID 00859337007110

MegaBeam® Single Use, Handpiece

WISDOM MEDICAL TECHNOLOGY, LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00859337007110
• NIH Device Record Key: 56cca247-2007-4a4b-a097-d9c01a003f73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaBeam
• Version Model Number: ENT-20-US-IC
• Catalog Number: ENT-20-US-IC
• Company DUNS: 080537625
• Company Name: WISDOM MEDICAL TECHNOLOGY, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net
• Phone: 630-803-6383
• Email: jfurcht@verizon.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859337007110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113709

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-12
• Device Publish Date: 2019-11-04

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