FDA.reportPublic FDA data

StarTrol

Primary DI
M5759X3GSW0
Brand
StarTrol
Company
HUOT INSTRUMENTS, LLC
Model
9X3-GSW
Catalog number
9X3-GSW
Device description
9 Pod Wall LED Light
Published
2017-01-17
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
M5759X3GSW0PrimaryHIBCC0

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850009233049BihlerMedBihlerMed, L.L.C.FTD2026-07-24
10850009233056BihlerMedBihlerMed, L.L.C.FTD2026-07-24
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
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03700712436261VolistaMAQUET SASFSY2026-07-20
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03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20