FDA.reportPublic FDA data

ILO

Primary DI
04250369707362
Brand
ILO
Company
ILO electronic GmbH
Model
M-X 300A
Catalog number
818-0004
Device description
300W xenon light source
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCTLight Source, Endoscope, Xenon Arc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCTLight Source, Endoscope, Xenon ArcGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250369707362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250369707362042503697073624250369707362

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49410677580info@ilo.com

Regulatory Flags#

DUNS number
341983849
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250369709304ILOLED50-HD II862-25112024-09-09
04250369709762ILOLED50-HD II RW US862-25192024-09-09
04250369708161ILOLED 50-HD862-22512023-06-22
04250369708178ILOLED 50-HD-USB862-22012023-06-22
04250369709021ILOLED50-EcoHD II862-25012023-06-22
04250369709755ILOCamera head LED50-HDII740-20202024-09-09
04250369709779ILOCamera head LED50-HDII740-20212024-09-09
04250369706051ILOM-CAM 1HD USB853-02022023-06-22
04250369706099ILOSwift 1HD USB853-02012023-06-22
04250369706273ILOM-CAM 1HD853-00012023-06-22
04250369706655ILOTRIstar 4K USB854-00302023-06-22
04250369706709ILOTRIstar 4K854-00292023-06-22
04250369706716ILOM-CAM 4K854-00312023-06-22
04250369706723ILOM-CAM 4K USB854-00322023-06-22
04250369706747ILOLED 2500825-02012023-06-22
04250369706754ILOM-LED 2500825-02022023-06-22
04250369706761ILOLED 3000plus825-03012023-06-22
04250369706778ILOLED 3000Tplus825-03032023-06-22
04250369706785ILOM-LED 3000plus825-03022023-06-22
04250369706792ILOM-LED 3000Tplus825-03042023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854080634CONMEDConmed CorporationGCT2026-03-24
10845854041291CONMEDConmed CorporationGCT2026-03-24
00840183528607BR Surgical, LLCBR Surgical, LLCGCT2024-10-24
04048551057261n.a.Karl Storz GmbH & Co. KGGCT2024-10-16
00857556008468BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008475BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008543BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
10845854041307CONMEDConmed CorporationGCT2023-12-04
10845854041314CONMEDConmed CorporationGCT2023-12-04
04961333083701PENTAXHOYA CORPORATIONGCT2023-07-31
04250369707317ILOILO electronic GmbHGCT2023-06-22
04250369707324ILOILO electronic GmbHGCT2023-06-22
04250369707348ILOILO electronic GmbHGCT2023-06-22
04250369707355ILOILO electronic GmbHGCT2023-06-22
04250369707379ILOILO electronic GmbHGCT2023-06-22
04250369707690ILOILO electronic GmbHGCT2023-06-22
04250369707706ILOILO electronic GmbHGCT2023-06-22
04250369707713ILOILO electronic GmbHGCT2023-06-22
04250369707720ILOILO electronic GmbHGCT2023-06-22
04250369707737ILOILO electronic GmbHGCT2023-06-22
04250369707744ILOILO electronic GmbHGCT2023-06-22
04953170400476XENON LUMPOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-18
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-17
04048551166116n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551325995n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346266n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346273n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346303n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551062838n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
00857580006669Light SourceGULF FIBEROPTICS, INC.GCT2017-12-01