FDA.reportPublic FDA data

StarTrol

Primary DI
M5754X3GS10
Brand
StarTrol
Company
HUOT INSTRUMENTS, LLC
Model
4X3-GS1
Catalog number
4X3-GS1
Device description
4 Pod Single 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
M5754X3GS10PrimaryHIBCC0

GMDN Terms#

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

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
M5754X3GS20StarTrol4X3-GS24X3-GS22017-02-09
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