OtoLase™ Straight Tip Package

GUDID 17290109142606

LUMENIS LTD.

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• Primary Device ID: 17290109142606
• NIH Device Record Key: f4abd7d3-25c2-41da-9989-4d78cffbdd5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OtoLase™ Straight Tip Package
• Version Model Number: OtoLase™ Straight Tip Package
• 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 Dimensions

• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter
• Lumen/Inner Diameter: 250 Micrometer
• Outer Diameter: 700 Micrometer
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109142609 [Primary]
GS1	17290109142606 [Package]; Contains: 07290109142609; Package: [12 Units]; In Commercial Distribution

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: 2016-10-05

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