UroFlex™ N

GUDID 03760187912097

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe Confocal endomicroscopy system probe

• Primary Device ID: 03760187912097
• NIH Device Record Key: a22983b6-4b03-4b1c-bd7e-6c28c3ef74d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroFlex™ N
• Version Model Number: FP-10037
• Company DUNS: 394136118
• Company Name: MAUNA KEA TECHNOLOGIES
• 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

Customer Support Contacts

• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com
• Phone: +33170080967
• Email: support@maunakeatech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760187912097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193416

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

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

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

[03760187912097]

High-level Disinfectant;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-15

Devices Manufactured by MAUNA KEA TECHNOLOGIES

• 03760187913001 - Cellvizio® I.V.E.: 2024-03-07
• 03760187910772 - AQ-Flex™ 19-C: 2023-02-17
• 03760187912004 - Cellvizio® I.V.E.: 2020-05-25
• 03760187912011 - AlveoFlex™ N: 2020-05-25
• 03760187912028 - GastroFlex™ N: 2020-05-25
• 03760187912035 - ColoFlex™ N: 2020-05-25
• 03760187912042 - CystoFlex™ R N: 2020-05-25
• 03760187912059 - AQ-Flex™ 19 N: 2020-05-25