FDA.reportPublic FDA data

Fiberoptics Technology Inc

Primary DI
00862658000326
Brand
Fiberoptics Technology Inc
Company
FIBEROPTICS TECHNOLOGY, INC.
Model
FTIHL
Device description
Adjustable Surgical Headlight
Published
2021-07-26
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
FCTHeadlight, Fiberoptic Focusing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862658000326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862658000326008626580003268626580003260862658000326

GMDN Terms#

Term, Definition table
TermDefinition
Headband, reusableA device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8609280443tbeeman@fiberoptix.com

Regulatory Flags#

DUNS number
088324827
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862658000333Fiberoptics Technology INCFTIMG 3.5mm2023-01-25
00862658000340Fiberoptics Technology INCFTIMG 5mm2023-01-25
00862658000302Fiberoptics Technology IncLO-502017-04-20
00862658000319Fiberoptics Technology IncFiber Optic Medical Light Guide2017-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013851521Altair HI 2QED, INC.FCT2025-05-21
00860013851538Altair SAQED, INC.FCT2025-05-21
00840183529192BR Surgical, LLCBR Surgical, LLCFCT2024-12-02
00840183500559BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183501136BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183512989BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00816835023967IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023974IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023981IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023998IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024018IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024025IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024032IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024056Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024063Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023950IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023966IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023973IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023980IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023997IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024017IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024024IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024031IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024055Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024062Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
B366HDL200FIBEROPTIC HEADLUXEclerisFCT2022-06-10
04055207008751NARichard Wolf GmbHFCT2018-10-17
M678HL0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
M678HLM0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
00841645132004ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFCT2016-09-26