FDA.reportPublic FDA data

Fiber Optic Light Cable

Primary DI
00857580006744
Brand
Fiber Optic Light Cable
Company
GULF FIBEROPTICS, INC.
Model
4.6mm bundle diameter, 9.9' length, Bifurcated Cab
Catalog number
169-500-S
Device description
A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.
Published
2020-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDGRetractor, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857580006744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857580006744008575800067448575800067440857580006744

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument fibreoptic lightA sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
815-855-6618contact@gulffiberoptics.com

Regulatory Flags#

DUNS number
017416582
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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G14157210690Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210870Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210920Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G1415543110400Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157204210Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210130Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210200Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572103590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210570Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210670Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572107270Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210830Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
00840329838867N/ABLACK & BLACK SURGICAL, INC.FDG2026-09-29
G425110676LSI0My MedicalMy Medical Store LLCFDG2026-05-04
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00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.FDG2026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.FDG2026-04-17
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.FDG2026-01-29
00812432023164Medtronic 4mm Universal Reusable Light CableLumitex, Inc.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLumitex, Inc.FDG2026-01-07
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