FDA.reportPublic FDA data

Light Source

Primary DI
00857580006669
Brand
Light Source
Company
GULF FIBEROPTICS, INC.
Model
300 Watt Xenon Light Source
Published
2017-12-01
Public version status
Update
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
00857580006669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857580006669008575800066698575800066690857580006669

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides 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
813-855-6618contact@gulffiberoptics.com

Regulatory Flags#

DUNS number
017416582
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857580006829Fiber Optic Light Cable3.8mm bundle diameter, 10' length, bifurcated cabl2025-02-26
00857580006812Fiber Optic Light Cable"2.0mm bundle diameter, 10"" length, mono cable"2024-10-15
00857580006805Fiber Optic Light Cable3.5mm bundle diameter, 9' length, bifurcated cable2024-06-07
00857580006782Fiber Optic Light Cable4.8mm bundle diameter, 10' length, bifurcated cabl2023-03-06
00857580006799Fiber Optic Light Cable"4.8mm bundle diameter, 18"" length, mono cable"2023-03-06
00857580006775Fiber Optic Light Cable3.0mm bundle diameter, 11' length, bifurcated cabl2021-10-20
00857580006768Fiber Optic Light Cable3.0mm bundle diameter, 12' length, mono cable2021-03-18
00857580006751Fiber Optic Light Cable4.8mm bundle diameter, 12' length, bifurcated cabl2021-02-18
00857580006003Fiber Optic Light Cable2.2mm bundle diameter, 6' length, mono cable2016-09-01
00857580006010Fiber Optic Light Cable2.2mm bundle diameter, 8' length, mono cable2016-09-01
00857580006027Fiber Optic Light Cable2.2mm bundle diameter, 10' length, mono cable2016-09-01
00857580006034Fiber Optic Light Cable2.8mm bundle diameter, 10' length, mono cable2016-09-01
00857580006041Fiber Optic Light Cable3.0mm bundle diameter, 6' length, mono cable2016-09-01
00857580006058Fiber Optic Light Cable3.0mm bundle diameter, 8' length, mono cable2016-09-01
00857580006065Fiber Optic Light Cable3.0mm bundle diameter, 10' length, mono cable2016-09-01
00857580006072Fiber Optic Light Cable3.0mm bundle diameter, 12' length, mono cable2016-09-01
00857580006089Fiber Optic Light Cable3.8mm bundle diameter, 6' length, mono cable2016-09-01
00857580006096Fiber Optic Light Cable3.8mm bundle diameter, 8' length, mono cable2016-09-01
00857580006102Fiber Optic Light Cable3.8mm bundle diameter, 9' length, mono cable2016-09-01
00857580006119Fiber Optic Light Cable3.8mm bundle diameter, 10' length, mono cable2016-09-01

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
04250369707362ILOILO 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