Gemini EVO G2-5-008

GUDID 00850010501109

Refill accessory for Gemini EVO laser

AZENA MEDICAL, LLC

Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system

• Primary Device ID: 00850010501109
• NIH Device Record Key: 4f064d2c-de64-4d9a-b125-455154d682e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gemini EVO
• Version Model Number: 9124
• Catalog Number: G2-5-008
• 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	00850010501109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210350

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2022-05-23
• Device Publish Date: 2022-05-13

On-Brand Devices [Gemini EVO]

• 00850010501086: Gemini EVO Demo Laser Unit
• 00850010501079: Gemini EVO International Laser
• 00850010501062: Gemini EVO Domestic Laser
• 00850010501130: Refill/accessory for Gemini EVO laser handpiece shell
• 00850010501123: Refill/accessory for International Power supply for Gemini EVO
• 00850010501116: Refill/accessory for power supply for Gemini EVO
• 00850010501109: Refill accessory for Gemini EVO laser
• 00850010501093: Refill accessory for Gemini EVO kit