StarTrol

Basic Information

• Brand Name: StarTrol
• Primary DI: M5751X3SFT0
• Version / Model: 1X3-SFT
• Catalog Number: 1X3-SFT
• Company Name: HUOT INSTRUMENTS, LLC
• Labeler DUNS: 780642844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-17
• Public Version: 3
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: c9c2feeb-031d-4271-9368-4632660cc50c

Device Description

1 Pod Super Flex Table Mount LED Light

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: MR Unsafe
• 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
KZF	DEVICE, MEDICAL EXAMINATION, AC POWERED	General Hospital	880.6320	1
FTD	Lamp, surgical	General, Plastic Surgery	878.4580	2
FSY	Light, surgical, ceiling mounted	General, Plastic Surgery	878.4580	2
FSS	Light, surgical, floor standing	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36843	Mobile examination/treatment room light	A mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.	No	Active
12276	Fixed examination/treatment room light	A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M5751X3SFT0	HIBCC

Customer Contacts

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