FDA.reportPublic FDA data

StarTrol

Primary DI
M5754X3GS20
Brand
StarTrol
Company
HUOT INSTRUMENTS, LLC
Model
4X3-GS2
Catalog number
4X3-GS2
Device description
4 Pod Dual Ceiling LED Light
Published
2017-02-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSSLight, surgical, floor standing
FSYLight, surgical, ceiling mounted
FTDLamp, surgical
KZFDEVICE, MEDICAL EXAMINATION, AC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2
FTDLamp, SurgicalGeneral, Plastic Surgery2
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5754X3GS20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mobile examination/treatment room lightA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(262)373-1700Anne.Ward@StarTrol.com

Regulatory Flags#

DUNS number
780642844
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5751X3M0StarTrol1X3-M1X3-M2017-01-17
M5751X3SFM0StarTrol1X3-SFM1X3-SFM2017-01-17
M5751X3SFT0StarTrol1X3-SFT1X3-SFT2017-01-17
M5751X3W0StarTrol1X3-W1X3-W2017-01-17
M5752X3M0StarTrol2X3-M2X3-M2017-01-17
M5752X3W0StarTrol2X3-W2X3-W2017-01-17
M5753X3M0StarTrol3X3-M3X3-M2017-01-17
M5753X3W0StarTrol3X3-W3X3-W2017-01-17
M57548X4GS20StarTrol4/8X4-GS24/8X4-GS22017-02-09
M57549X3GS20StarTrol4/9X3-GS24/9X3-GS22017-02-09
M5754X3GS10StarTrol4X3-GS14X3-GS12017-02-09
M5754X3GSW0StarTrol4X3-GSW4X3-GSW2017-01-17
M5754X3M0StarTrol4X3-M4X3-M2017-01-17
M5754X4GS10StarTrol4X4-GS14X4-GS12017-02-09
M5754X4GS20StarTrol4X4-GS24X4-GS22017-02-09
M5754X4GSW0StarTrol4X4-GSW4X4-GSW2017-01-17
M5754X4M0StarTrol4X4-M4X4-M2017-01-17
M5758X4GS10StarTrol8X4-GS18X4-GS12017-02-09
M5758X4GS20StarTrol8X4-GS28X4-GS22017-02-09
M5758X4GSW0StarTrol8X4-GSW8X4-GSW2017-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
10686864056819Medicom SafeMaskAMD Medicom IncFSS2025-01-23
14026704741837PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFTD2023-05-29
08881300212001KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITEDFTD2023-03-13
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFTD2023-03-01
10841736123161Lumos Surgical Light SeriesSKYTRON LLCFSS2022-02-15
10840143902017DissectorATRICURE, INC.FTD2021-01-11
10840143902130DissectorATRICURE, INC.FTD2021-01-11
10865082000181View Medical SurgiLightBihlerMed, L.L.C.FTD2019-08-05
M710SL120SurgiLux™BIOTEX, INC.FTD2019-07-01
10841736113858Skytron DoVeraSKYTRON LLCFSS2018-08-01
M678SLS0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFTD2018-06-27
10884521547636DevonCardinal Health, Inc.FSY2018-05-11
10884521739635DevonCardinal Health, Inc.FSY2017-10-20
M678XLS0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFSS2017-09-29
10884521739642DevonCardinal Health, Inc.FSY2017-08-08
M678ROVER0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFTD2017-05-09
10841736110536AURORA SURGICAL LIGHT SERIESSKYTRON LLCFSY2017-04-04
M57548X4GS20StarTrolHUOT INSTRUMENTS, LLCFTD2017-02-09
M57548X4GS20StarTrolHUOT INSTRUMENTS, LLCFSY2017-02-09
M57548X4GS20StarTrolHUOT INSTRUMENTS, LLCFSS2017-02-09
M57549X3GS20StarTrolHUOT INSTRUMENTS, LLCFSY2017-02-09
M57549X3GS20StarTrolHUOT INSTRUMENTS, LLCFTD2017-02-09