Cellvizio® I.V.E.

Basic Information

• Brand Name: Cellvizio® I.V.E.
• Primary DI: 03760187912004
• Version / Model: FP-10001
• 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: 1
• Public Version Date: 2020-05-25
• Public Version Status: New
• Public Device Record Key: ef89069f-47bc-4ac7-a9f0-9ebcca0a565e

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
62287	Confocal endomicroscopy system	An assembly of mains electricity-powered (AC-powered) devices designed to visualize microscopic cellular and tissue structures during an endoscopic, interventional or surgical procedure to provide real-time images to facilitate further treatment planning. It is based on fluorescence confocal microscopy and typically consists of the confocal laser scanning unit, hand/foot controls, an endoscopic fibreoptic probe, and an image processing and display unit for visualization and/or recording.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760187912004	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193416	000