Quest Spectrum Platform

Basic Information

• Brand Name: Quest Spectrum Platform
• Primary DI: 08719324487009
• Version / Model: ART-SYS-0019
• Catalog Number: ART-SYS-0019
• Company Name: Quest Projects B.V.
• Labeler DUNS: 386614502
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cde476bc-d1f1-43ec-9534-5848849baf05

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
OWN	Confocal Optical Imaging	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57883	Surgical microscope fluorescent angiography system	A non-sterile, mains electricity (AC-powered) device assembly designed for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. It enables a surgical microscope to produce excitation light and resolve fluorescence from the fluorescent agent indocyanine green (ICG). Fluorescent signals depict the distribution of the infrared dye in the patient's blood vessels during the operation. The system is attached to a compatible surgical microscope and typically includes an ICG filter, a near infrared (NIR) charge-coupled device (CCD) video camera, and connecting cables.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719324487009	GS1

Customer Contacts

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