CONVIVO

GUDID 04049539069184

Carl Zeiss Meditec AG

Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope

• Primary Device ID: 04049539069184
• NIH Device Record Key: fcc75a21-02e9-445b-a331-67ac94ea3cd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONVIVO
• Version Model Number: 6918
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• 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: true
• 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	04049539069184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181116

FDA Product Code

• LLZ: System, Image Processing, Radiological
• OWN: Confocal Optical Imaging

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: 2019-12-23
• Device Publish Date: 2019-12-13

Devices Manufactured by Carl Zeiss Meditec AG

• 04049471100143 - Treatment Pack (Size M): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100150 - Treatment Pack (Size L): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100167 - Treatment Pack (Type KP): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100136 - Treatment Pack (Size S): 2024-02-16 single use accessory for ZEISS femtosecond lasers
• 04049539101341 - EyeMag Smart: 2023-11-16
• 04049539101358 - EyeMag Pro S: 2023-11-16
• 04049539101365 - EyeMag Pro F: 2023-11-16
• 04049539064103 - PENTERO® 800 S: 2023-09-19