Fluorescence Mode

GUDID 06977585090143

Carl Zeiss Meditec (Suzhou) Co., Ltd.

Dental surgical microscope

• Primary Device ID: 06977585090143
• NIH Device Record Key: 19aa5bc1-70f1-4fc0-93ad-ecf572afa0df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorescence Mode
• Version Model Number: 000000-2165-387
• Company DUNS: 631835173
• Company Name: Carl Zeiss Meditec (Suzhou) Co., Ltd.
• 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	06977585090143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171007

FDA Product Code

• NBL: Laser, Fluorescence Caries Detection

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: 2025-04-03
• Device Publish Date: 2025-03-26

Devices Manufactured by Carl Zeiss Meditec (Suzhou) Co., Ltd.

• 06977585090013 - OPMI LUMERA 300: 2025-04-03 No description
• 06977585090051 - EXTARO 300: 2025-04-03
• 06977585090099 - EXTARO 300: 2025-04-03 No device description
• 06977585090129 - EXTARO 300: 2025-04-03 No device description
• 06977585090136 - EXTARO 300: 2025-04-03 No device description
• 06977585090143 - Fluorescence Mode: 2025-04-03
• 06977585090143 - Fluorescence Mode: 2025-04-03