Fiber Optic Light Cable - A flexible fiber optic cable that is designed to - GULF FIBEROPTICS, INC.

Duns Number:017416582

Device Description: A flexible fiber optic cable that is designed to transport light from a light source to an A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g. and 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.

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More Product Details

Catalog Number

-

Brand Name

Fiber Optic Light Cable

Version/Model Number

2.8mm bundle diameter, 8' length, mono cable

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K021931

Product Code Details

Product Code

FFS

Product Code Name

Image, Illumination, Fiberoptic, For Endoscope

Device Record Status

Public Device Record Key

41e0cc24-6a08-4d04-b579-54aa1c05a9d3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GULF FIBEROPTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 76