Gemini 810+980 Diode Laser Kit, International

GUDID 00861407000389

AZENA MEDICAL, LLC

Dental diode laser system

• Primary Device ID: 00861407000389
• NIH Device Record Key: b4319f84-e644-4782-8688-52108d0d26cb
• Commercial Distribution Discontinuation: 2021-07-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gemini 810+980 Diode Laser Kit, International
• Version Model Number: 8990
• 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	00861407000389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192617

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

[00861407000389]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-30
• Device Publish Date: 2021-07-22

Devices Manufactured by AZENA MEDICAL, LLC

• 00861407000310 - Gemini: 2023-11-13 Gemini 5mm Tip - 25pk
• 00861407000327 - Gemini: 2023-11-13 Gemini 7mm Tip - 25pk
• 00861407000334 - Gemini: 2023-11-13 Gemini Safety Glasses
• 00850010501093 - Gemini EVO: 2022-05-23 Refill accessory for Gemini EVO kit
• 00850010501109 - Gemini EVO: 2022-05-23 Refill accessory for Gemini EVO laser
• 00850010501116 - Gemini EVO: 2022-05-23 Refill/accessory for power supply for Gemini EVO
• 00850010501123 - Gemini EVO: 2022-05-23 Refill/accessory for International Power supply for Gemini EVO
• 00850010501130 - GEMINI EVO: 2022-05-23 Refill/accessory for Gemini EVO laser handpiece shell