Sunoptic Technologies

Basic Information

• Brand Name: Sunoptic Technologies
• Primary DI: M678ROVER0
• Version / Model: Rover Lightsource series
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• Labeler DUNS: 094586898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 926ee2e9-4531-4b68-ac27-a243cba1427d

Device Description

Rover lightsource series

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38832	Hand-held examination/treatment light	A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M678ROVER0	HIBCC

Customer Contacts

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