MegaBeam 101256

GUDID 00859337007066

MegaBeam 400um SMA, radial emitting laser fiber, single use

WISDOM MEDICAL TECHNOLOGY, LLC

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00859337007066
• NIH Device Record Key: 3fbaf5bb-6d0b-488c-8d60-1128e464226a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaBeam
• Version Model Number: 101256
• Catalog Number: 101256
• 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	00859337007066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112442

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-06

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