Gemini 810+980 Diode Laser Kit, International

GUDID 00861407000389

AZENA MEDICAL, LLC

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