CystoFlex™F MP-0012-CYS-CK

GUDID 00827002472747

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system probe

• Primary Device ID: 00827002472747
• NIH Device Record Key: aa5827cd-623f-4d62-a380-03ccb0ecc7f7
• Commercial Distribution Discontinuation: 2020-04-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CystoFlex™F
• Version Model Number: 211-0146
• Catalog Number: MP-0012-CYS-CK
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002472747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132389

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

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

[00827002472747]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-07
• Device Publish Date: 2016-12-12

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