Micro-G™ Otology Kit

GUDID 07290109142074

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system

• Primary Device ID: 07290109142074
• NIH Device Record Key: ec7b2b1b-b173-4175-9bf3-5fb82a63232d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-G™ Otology Kit
• Version Model Number: Micro-G™ Otology Kit
• Company DUNS: 600166524
• Company Name: LUMENIS LTD.
• 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: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx
• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109142074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100384

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: 2016-08-30

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