Fiber Optic Light Cable

FDA UDI

Class I (US FDA UDI)

by Gulf Fiberoptics, Inc.

Identity

Trade Name: Fiber Optic Light Cable FDA UDI
Generic Name: Surgical instrument fibreoptic light FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 4.6mm bundle diameter, 10' length, Bifurcated Cable FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 27436-3-S FDA UDI
Primary DI / UDI-DI: 00857580006720 FDA UDI
FDA Product Code: FDG FDA UDI
GMDN Term: Surgical instrument fibreoptic light FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument fibreoptic light

Fiber Optic Light Cable by Gulf Fiberoptics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Gulf Fiberoptics, Inc.

Sources (1)

FDA UDI ea8fabce-1c4f-4a57-b283-cbb46c8ff34d 35 fields · synced May 31, 2026