AccessGUDID - DEVICE: StarTrol (M5754X3GS10)

GUDID

Device Identifier (DI) Information

Brand Name: StarTrol
Version or Model: 4X3-GS1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4X3-GS1
Company Name: HUOT INSTRUMENTS, LLC

Primary DI Number: M5754X3GS10
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 780642844 *Terms of Use

Device Description: 4 Pod Single Ceiling LED Light

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTD	Lamp, surgical
FSY	Light, surgical, ceiling mounted
KZF	DEVICE, MEDICAL EXAMINATION, AC POWERED
FSS	Light, surgical, floor standing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab4765b9-392d-46b9-9b9a-a192c8f8ca64
Public Version Date: January 08, 2021
Public Version Number: 3
DI Record Publish Date: February 09, 2017