Fluorescence Mode 000000-2165-387

GUDID 06909262100043

Carl Zeiss Suzhou Co., Ltd.

Dental surgical microscope

• Primary Device ID: 06909262100043
• NIH Device Record Key: 83050910-b412-4728-b6c3-f4b9931ff3e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorescence Mode
• Version Model Number: 000000-2165-387
• Catalog Number: 000000-2165-387
• Company DUNS: 528182577
• Company Name: Carl Zeiss Suzhou Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06909262100043 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-29
• Device Publish Date: 2018-09-25

Devices Manufactured by Carl Zeiss Suzhou Co., Ltd.

• 06909262060330 - EXTARO® 300: 2022-08-19
• 06909262060347 - EXTARO® 300: 2022-08-19
• 06909262060354 - EXTARO® 300: 2022-08-19
• 06909262061375 - OPMI® LUMERA® 300: 2022-08-19 No description
• 06909262100104 - EXTARO® 300: 2022-08-19
• 06909262200040 - ZEISS Axio Vert: 2021-01-11
• 06909262200057 - ZEISS Axio Vert: 2021-01-11
• 06909262200064 - ZEISS Axio Vert: 2021-01-11