FDA.reportPublic FDA data

Fiber Optic Light Cable

Primary DI
00857580006065
Brand
Fiber Optic Light Cable
Company
GULF FIBEROPTICS, INC.
Model
3.0mm bundle diameter, 10' length, mono cable
Device description
A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fiber optic bundle is protected within a sheath and is made of glass fibers. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fiber optic bundle. This is a reusable device.
Published
2016-09-01
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
FFSImage, Illumination, Fiberoptic, For Endoscope
HBIIlluminator, Fiberoptic, Surgical Field

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFSImage, Illumination, Fiberoptic, For Endoscope Gastroenterology, Urology2
HBIIlluminator, Fiberoptic, Surgical FieldGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021931000ENDOSCOPIC FIBEROPTIC CABLEGulf Medical Fiberoptics2002-09-06HBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857580006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857580006065008575800060658575800060650857580006065

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
813-855-6618contact@gulffiberoptics.com

Regulatory Flags#

DUNS number
017416582
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
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
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
00857580006126Fiber Optic Light Cable4.25mm bundle diameter, 10' length, mono cable2016-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419067Bausch + LombBausch & Lomb IncorporatedHBI2026-04-30
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B382SD77321140Surgical DirectSurgical Direct, Inc.FFS2026-02-03
B382SD97321140Surgical DirectSurgical Direct, Inc.FFS2026-02-02
B382SD97321150Surgical DirectSurgical Direct, Inc.FFS2026-02-02
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B382SD92422150Surgical DirectSurgical Direct, Inc.FFS2025-03-17
B382SD512531150Surgical DirectSurgical Direct, Inc.FFS2025-03-10
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2025-02-26
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2025-02-26
B382SD123200Surgical DirectSurgical Direct, Inc.FFS2024-12-12
00821925008892GYRUS ACMI, INCGyrus ACMI, LLCFFS2024-11-25
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-10-15
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2024-10-15
B382SD52321110Surgical DirectSurgical Direct, Inc.FFS2024-08-08
B382SD82421110Surgical DirectSurgical Direct, Inc.FFS2024-08-01
00816744027728NICO Myriad SPECTRANICO CORPORATIONHBI2024-06-07
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2024-06-07
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-06-07
B382SD81531140Surgical DirectSurgical Direct, Inc.FFS2024-03-12
B382SD82131160Surgical DirectSurgical Direct, Inc.FFS2024-03-12
B382SD42531170Surgical DirectSurgical Direct, Inc.FFS2024-02-23
B382SD4810450Surgical DirectSurgical Direct, Inc.FFS2024-01-31
00816835024216OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
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