OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™

GUDID 07290109142968

Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07290109143965 07290109143972 07290109143989

LUMENIS LTD.

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

• Primary Device ID: 07290109142968
• NIH Device Record Key: fe80bd62-1368-4cb7-9542-f1db9067bf11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
• Version Model Number: Kit for up to 007-xxxx, 110V
• 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: false
• Lot Batch: false
• Serial Number: false
• 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: 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
• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109142968 [Primary]
GS1	07290109143903 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151331

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

[07290109142968]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-29
• Device Publish Date: 2016-09-19

On-Brand Devices [OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™ ]

• 07290109142968: Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07
• 07290109142692: Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07