FDA Registration
Active
🇺🇸 United States
GULF FIBEROPTICS, INC.
Reg #: 3003768921
·
FEI: 3003768921
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GULF FIBEROPTICS, INC.
- Registration Number
- 3003768921
- FEI Number
- 3003768921
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 448 Commerce Blvd
- City
- OLDSMAR
- State
- FL
- ZIP
- 34677
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061690
Owner / Operator
- Firm Name
- GULF FIBEROPTICS, INC
- Operator Number
- 9051646
- Address
- 448 Commerce Blvd., --
- City
- Oldsmar
- State
- FL
- Postal Code
- 34677
- Country
- US
- Correspondent
- Patrick - Bennetts
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2007-12-03 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2019-10-23 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2017-09-25 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2007-12-03 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 2007-12-03 |
Proprietary Names
Visualux Fiber Optic Surgical Headlight
Retractor Illumination Light Cable
Gulf Fiberoptics Visualux 300T Xenon Light Source
Rigid Endoscope Fiber Optic Light Cord
Gulf Fiberoptics Rigid Endoscope Fiber Optic Light Cord
Establishment Types
Manufacture Medical Device