Fiber Optic Light Cable

Basic Information

• Brand Name: Fiber Optic Light Cable
• Primary DI: 00857580006409
• Version / Model: 5.5mm bundle diameter, 192" length, mono cable
• Company Name: GULF FIBEROPTICS, INC.
• Labeler DUNS: 017416582
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 16f1f553-cf2a-4842-a721-315717970096

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	876.1500	2
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35507	Fibreoptic light cable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857580006409	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021931	000