FDA.reportPublic FDA data

Surgical Headlight

Primary DI
00857580006737
Brand
Surgical Headlight
Company
GULF FIBEROPTICS, INC.
Model
Light Weight Single Adjustable Headgear
Device description
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.
Published
2019-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSTLight, Surgical, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061690000SURGICAL HEADLIGHTGulf Medical Fiberoptics2006-09-15FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857580006737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857580006737008575800067378575800067370857580006737

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn fibreoptic lightA fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
813-855-6618contact@gulffiberoptics.com

Regulatory Flags#

DUNS number
017416582
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857580006829Fiber Optic Light Cable3.8mm bundle diameter, 10' length, bifurcated cabl2025-02-26
00857580006812Fiber Optic Light Cable"2.0mm bundle diameter, 10"" length, mono cable"2024-10-15
00857580006805Fiber Optic Light Cable3.5mm bundle diameter, 9' length, bifurcated cable2024-06-07
00857580006782Fiber Optic Light Cable4.8mm bundle diameter, 10' length, bifurcated cabl2023-03-06
00857580006799Fiber Optic Light Cable"4.8mm bundle diameter, 18"" length, mono cable"2023-03-06
00857580006775Fiber Optic Light Cable3.0mm bundle diameter, 11' length, bifurcated cabl2021-10-20
00857580006768Fiber Optic Light Cable3.0mm bundle diameter, 12' length, mono cable2021-03-18
00857580006751Fiber Optic Light Cable4.8mm bundle diameter, 12' length, bifurcated cabl2021-02-18
00857580006003Fiber Optic Light Cable2.2mm bundle diameter, 6' length, mono cable2016-09-01
00857580006010Fiber Optic Light Cable2.2mm bundle diameter, 8' length, mono cable2016-09-01
00857580006027Fiber Optic Light Cable2.2mm bundle diameter, 10' length, mono cable2016-09-01
00857580006034Fiber Optic Light Cable2.8mm bundle diameter, 10' length, mono cable2016-09-01
00857580006041Fiber Optic Light Cable3.0mm bundle diameter, 6' length, mono cable2016-09-01
00857580006058Fiber Optic Light Cable3.0mm bundle diameter, 8' length, mono cable2016-09-01
00857580006065Fiber Optic Light Cable3.0mm bundle diameter, 10' length, mono cable2016-09-01
00857580006072Fiber Optic Light Cable3.0mm bundle diameter, 12' length, mono cable2016-09-01
00857580006089Fiber Optic Light Cable3.8mm bundle diameter, 6' length, mono cable2016-09-01
00857580006096Fiber Optic Light Cable3.8mm bundle diameter, 8' length, mono cable2016-09-01
00857580006102Fiber Optic Light Cable3.8mm bundle diameter, 9' length, mono cable2016-09-01
00857580006119Fiber Optic Light Cable3.8mm bundle diameter, 10' length, mono cable2016-09-01

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