FDA.reportPublic FDA data

STARLED3 NX

Primary DI
08050705890415
Brand
STARLED3 NX
Company
ACEM SPA
Model
STARLED3 NX /W
Catalog number
110602
Device description
STARLED3 NX WALL
Published
2020-02-04
Public version status
Update
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
08050705890415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050705890415080507058904158050705890415

GMDN Terms#

Term, Definition table
TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435188508
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
08050705890002CIRCLEDCIRCLED /R1100002020-01-31
08050705890019CIRCLEDCIRCLED /D1100012020-01-31
08050705890026CIRCLEDCIRCLED /W1100022020-01-31
08050705890033CIRCLEDCIRCLED /T1100032020-01-31
08050705890040ACEMST1ACEMST1.1 /RR1108002020-01-31
08050705890057ACEMST1ACEMST1.1 /RD1108012020-01-31
08050705890064ACEMST1ACEMST1.1 /RW1108022020-01-31
08050705890071ACEMST1ACEMST1.1 /RT1108032020-01-31
08050705890088ACEMST1ACEMST1.1 /RTB1108042020-01-31
08050705890095ACEMST1ACEMST1.1 /RC1108052020-01-31
08050705890101ACEMST1ACEMST1.3 /RR1110002020-01-31
08050705890118ACEMST1ACEMST1.3 /RD1110012020-01-31
08050705890125ACEMST1ACEMST1.3 /RW1110022020-01-31
08050705890132ACEMST1ACEMST1.3 /RT1110032020-01-31
08050705890149ACEMST1ACEMST1.3 /RTB1110042020-01-31
08050705890156ACEMST1ACEMST1.3 /RC1110052020-01-31
08050705890163ACEMST1ACEMST1.1 /FR1109002020-01-31
08050705890170ACEMST1ACEMST1.1 /FD1109012020-01-31
08050705890187ACEMST1ACEMST1.1 /FW1109022020-01-31
08050705890194ACEMST1ACEMST1.1 /FT1109032020-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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08800053093903S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093958S300 SeriesDENTIS CO. ,LTDFTD2025-02-19