Acculite™  EndoOcular®

GUDID 07290109140735

LUMENIS INC.

Ophthalmic laser system beam guide

• Primary Device ID: 07290109140735
• NIH Device Record Key: 3b4861cc-90e1-4dc6-935d-f136e7210186
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acculite™ EndoOcular®
• Version Model Number: Standard, 20ga str taper, 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	07290109140735 [Primary]
GS1	17290109140732 [Package]; Package: [10 Units]; Discontinued: 2016-09-11; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K812219

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

[07290109140735]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-11

On-Brand Devices [Acculite™  EndoOcular®]

• 17290109142781: Standard, 20ga str taper, SmartScan, 200µm
• 17290109140800: Illum/Sm Plug, 20ga 45°, SMA 906, 200µm
• 17290109140794: Illum/Lg Plug, 20ga 45°, SMA 906, 200µm
• 17290109140770: Illum/Lg Plug, 20ga str, SMA 906, 200µm
• 17290109140763: Aspirating, 20ga str, SMA 906, 200µm
• 17290109140756: " Aspirat., 20ga 45° bend, SMA 906, 200µm"
• 07290109140742: Standard, 20ga 20° bend, SMA 906, 200µm
• 07290109140735: Standard, 20ga str taper, SMA 906, 200μm
• 17290109140725: Standard, 20ga str taper, SMA 905, 200µm