Acculite EndoOto

GUDID 07290109140827

LUMENIS INC.

Ophthalmic laser system beam guide

• Primary Device ID: 07290109140827
• NIH Device Record Key: 030a7ff3-9ff1-4439-9425-e1df5df1b1dc
• Commercial Distribution Discontinuation: 2020-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acculite EndoOto
• Version Model Number: Gherini, 24ga Straight, SMA 906, 200µm
• Company DUNS: 043618763
• Company Name: LUMENIS INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109140827 [Primary]
GS1	17290109140824 [Package]; Package: [10 Units]; Discontinued: 2019-05-20; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930981

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290109140827]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-26

On-Brand Devices [Acculite EndoOto]

• 17290109140855: 24ga 15° Angled, SMA 905, 200µm
• 07290109140841: 24ga 10° Angled, SMA 905, 200µm
• 17290109140831: Horn, 24ga 20° Angled, SMA 906, 200µm
• 07290109140827: Gherini, 24ga Straight, SMA 906, 200µm