Endo kit with Fixed Eye Safety Filter

GUDID 00810096330277

Lumenis Be, Inc.

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• Primary Device ID: 00810096330277
• NIH Device Record Key: c4d87be6-7209-4554-bffd-70222fbbd960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo kit with Fixed Eye Safety Filter
• Version Model Number: Endo kit with Fixed 532/577/659 nm
• Company DUNS: 118292380
• Company Name: Lumenis Be, 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810096330277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151109

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-04-02

On-Brand Devices [Endo kit with Fixed Eye Safety Filter]

• 00810096330277: Endo kit with Fixed 532/577/659 nm
• 00810096330246: Endo kit with Fixed ESF 532 nm