FDA.reportPublic FDA data

IsoLED Flex I LED Exam Light

Primary DI
00816835024261
Brand
IsoLED Flex I LED Exam Light
Company
Medical Illumination International Inc.
Model
IL-2501
Device description
IsoLED Flex I LED Examination Light, Surgical Table Rail Mount
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816835024260PackageGS11In Commercial Distribution
00816835024261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816835024260018168350242601816835024260
00816835024261008168350242618168350242610816835024261

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.

Regulatory Flags#

DUNS number
093357739
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
00816835024384SYSTEM TWO LEDSD3CD3-CNE-LCH-4K2026-04-30
00816835024391SYSTEM TWO LEDSD3CD3-CNE-4K2026-04-30
00816835024407SYSTEM TWO LEDSD2CD2M1-LCH-4K2026-04-30
00816835024414SYSTEM TWO LEDSD3CDEM1-CNE-4K2026-04-30
00816835024421SYSTEM TWO LEDSD2C-LCH-4K2026-04-30
00816835024438SYSTEM TWO LEDSD3CD3M1M1-LCH-4K2026-04-30
00816835024445SYSTEM TWO LEDSD2CD2-4K2026-04-30
00816835024452SYSTEM TWO LEDSD2CD2-LCH-4K2026-04-30
00816835024469SYSTEM TWO LEDSD2CM1-LCH-4K2026-04-30
00816835024476SYSTEM TWO LEDSD3C-CNE-4K2026-04-30
00816835024483SYSTEM TWO LEDSD3CM1-CNE-LCH-4K2026-04-30
00816835023813VIDASHIELD/UV24071214/VS02D2022-12-16
01816835023812VIDASHIELD/UV24071214/VS02D2022-12-16
00816835024360Vu160NVSD3D3M1-LCH2025-02-19
00816835024353Vu160NVSD3M1-LCH2025-02-19
01816835024369Vu160NVSD3D3M1-LCH2025-02-19
00816835020409Vistor PRO LEDNV061513B2016-09-23
00816835024346SM1SM12024-09-04
01816835024345SM1SM12024-09-04
00816835024322MI-1000CAM061524CAM2024-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500176518382DermLite SkeenDermLite LLCKYT2026-09-28
00814005025650Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025667Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025674Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00814005023526RADBL25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023533RADBLC1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023540RADFILM5QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023571RADHU2QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023595RADHUM4QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023618RADINST1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024172RADC25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024189RADFILM6QUALITY ASPIRATORS, INC.KYT2025-02-27
008140050242572 Pin Detachable CableQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024288M-CZQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024295M-ORTTL AssemblyQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024301M-COQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024370M-KEQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024387M-HBQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024394M-ORQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024400M-QFQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024431M-SUQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024448M-SUTTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024455M-SVQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024462M-TTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024479RADFIL1QUALITY ASPIRATORS, INC.KYT2025-02-27