CystoFlex™ R N

Basic Information

• Brand Name: CystoFlex™ R N
• Primary DI: 03760187912042
• Version / Model: FP-10032
• Company Name: MAUNA KEA TECHNOLOGIES
• Labeler DUNS: 394136118
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-15
• Public Version: 2
• Public Version Date: 2021-07-26
• Public Version Status: Update
• Public Device Record Key: f9761571-2556-407d-b57a-3a7013cb63fe

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Hydrogen Peroxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWN	Confocal Optical Imaging	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62288	Confocal endomicroscopy system probe	A minimally-invasive distal component of an endomicroscopy system intended to capture real-time images of microscopic cellular and tissue structures during an endoscopic procedure. It is a flexible fibreoptic bundle typically connected to a laser scanning unit that channels a laser beam to the anatomical site of interest and allows visualization by detecting the fluorescence emitted by the cells in the targeted region. This is a reusable device intended to be sterilized or disinfected prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760187912042	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K193416	000