Gemini El-5-002

GUDID 00861407000334

Gemini Safety Glasses

AZENA MEDICAL, LLC

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• Primary Device ID: 00861407000334
• NIH Device Record Key: b9847acf-c614-4dce-ba1a-7cc0ba3be1e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gemini
• Version Model Number: 8985
• Catalog Number: El-5-002
• Company DUNS: 073483242
• Company Name: AZENA MEDICAL, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861407000334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192617

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: 2023-11-13
• Device Publish Date: 2023-11-03

On-Brand Devices [Gemini]

• 00861407000334: Gemini Safety Glasses
• 00861407000327: Gemini 7mm Tip - 25pk
• 00861407000310: Gemini 5mm Tip - 25pk