GULF FIBEROPTICS, INC.

Address:448 Commerce Blvd,OLDSMAR,FL,34677,US

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Device Description : A flexible fiber optic cable that is designed to transport light from a light so 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 Class : 2

Duns Number: 017416582

Premarket Exempt : No

Product Code : HBI, FFS

Prescription Use : No

Device Count : 1

Device Description : A flexible fiber optic cable that is designed to transport light from a light so 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 Class : 2

Duns Number: 017416582

Premarket Exempt : No

Product Code : FFS, HBI

Prescription Use : No

Device Count : 1

- Catalog Number : 27436-3-S

Device Description : A sterile device with a fibreoptic bundle core designed to be affixed to the sur 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.

Device Class : 1

Duns Number: 017416582

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : Yes

Device Count : 1

Device Description : A fiber optic lamp mounted on a headband frame and intended to be situated on th A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehead to provide light directly onto the field of vision during a medical or surgical procedure. The light typically consists of a magnifying lens, a reflector, and a fiber optic cable that conveys light from a connected light source.

Device Class : 2

Duns Number: 017416582

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

- Catalog Number : 169-500-S

Device Description : A sterile device with a fibreoptic bundle core designed to be affixed to the sur 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.

Device Class : 1

Duns Number: 017416582

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : Yes

Device Count : 1

Device Description : A flexible fiber optic cable that is designed to transport light from a light so 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.

Device Class : 2

Duns Number: 017416582

Premarket Exempt : No

Product Code : FFS, HBI

Prescription Use : No

Device Count : 1

Device Description : A flexible fiber optic cable that is designed to transport light from a light so 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 Class : 2

Duns Number: 017416582

Premarket Exempt : No

Product Code : HBI, FFS

Prescription Use : No

Device Count : 1

Device Description : A flexible fiber optic cable that is designed to transport light from a light so 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 Class : 2

Duns Number: 017416582

Premarket Exempt : No

Product Code : FFS, HBI

Prescription Use : No

Device Count : 1