FDA.reportPublic FDA data

S300 Series

Primary DI
08800053093903
Brand
S300 Series
Company
DENTIS CO. ,LTD
Model
S300-31001
Device description
AC 100-240V, 50/60Hz, 61-84VA(Non Camera)
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053093903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053093903088000530939038800053093903

GMDN Terms#

Term, Definition table
TermDefinition
Operating room light systemAn assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694721181
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800313230017ChecQPEGDCQP272026-08-26
08800313230024ChecQPEGDCQP382026-08-26
08800313230031ChecQPEGDCQP502026-08-26
08800313230048ChecQPEGDCQP532026-08-26
08800313230055ChecQPEGDCQP542026-08-26
08800313230062ChecQPEGDCQP632026-08-26
08800313237429ChecQPEGDCQP322026-08-26
08800313237436ChecQPEGDCQP572026-08-26
08800313237443ChecQPEGDCQP482026-08-26
08800313237450ChecQPEGDCQP602026-08-26
08800313237467ChecQPEGDCQP012026-08-26
08800313237474ChecQPEGDCQP032026-08-26
08800313237481ChecQPEGDCQP282026-08-26
08800313237498ChecQPEGDCQP492026-08-26
08800313237504ChecQPEGDCQP792026-08-26
08800313235449Guide Anchor PinDGAP142026-08-19
08800313235456Guide Bone AnchorDGBA132026-08-19
08800313235463Guide Bone AnchorDGBA112026-08-19
08800313235470Guide Bone AnchorDGBA092026-08-19
08800313235487Guide Fixture AnchorDGFAN132026-08-19

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
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
08800053093767S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093774S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093781S300 Series DENTIS CO. ,LTDFTD2025-02-19
08800053093798S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093804S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093828S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093835S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093842S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093859S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093866S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093873S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093880S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093897S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19